Alopecia
Conditions
Keywords
quality of life, safety, sexual function, male pattern hair loss (MPHL), Androgenic alopecia (AGA), dutasteride, satisfaction with hair growth
Brief summary
Treatment of male pattern hair loss (MPHL) or androgenetic alopecia (AGA) with 5α-reductase inhibitor (5-ARIs) has been associated with sexual dysfunction including erectile dysfunction and loss of libido. This will be a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the impact of dutasteride treatment on sexual function as well as subject satisfaction with hair growth and quality of life in men with AGA. This study will consist of a Screening Visit, a 4-week Placebo Run-in Phase, a Treatment Phase of 48 weeks, and a subsequent Follow-up Visit after 4 weeks. The treatment phase will include 24 weeks of double-blind, placebo controlled treatment and 24 weeks of open-label treatment with dutasteride. An extended 6-month Follow-up Visit will be conducted for any individuals with a change in erectile function at the end of treatment.
Interventions
DRUGDutasteride
Dutasteride will be supplied as soft gelatin capsules, containing 0.5 mg of dutasteride to be administered orally.
DRUGPlacebo
Dutasteride matching placebo will be supplied as capsules to be administered orally.
Sponsors
GlaxoSmithKline
Stiefel, a GSK Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Subject agrees to participate in the study and has signed and dated the informed consent form prior to the initiation of any study-related activities. * AGA classified utilizing the Norwood-Hamilton classification. * Men 18 to 50 years old, inclusively. * Fluent and literate in local language with the ability to comprehend and record information on the International Index of Erectile Function, Hair Growth Satisfaction Scale, and DLQI questionnaires. * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<2x upper limit of normal (ULN); alkaline phosphatase and bilirubin ≤1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin is \<35%). * Have been in a stable heterosexual relationship during the last 6 months prior to screening and expect to maintain that relationship throughout the study. * Must be sexually active: a man is considered sexually active if he has engaged in sexual intercourse (at least once) during the 4 weeks prior to screening. * Men with a female partner of childbearing potential must agree to avoid exposure of his partner to semen by using a condom. Use of a condom must be from 2 weeks prior to administration of the first dose of study treatment until at least 5 half-lives for the drug (45 days) plus 3 months (i.e., a total of 4.5 months) to allow clearance of any residual drug in the semen after the last dose of study treatment. * Willing to comply with study requirements.
Exclusion criteria
* Current or pre-existing sexual dysfunction as determined by: History of erectile dysfunction defined as the consistent inability to achieve or maintain an erection sufficient to permit satisfactory sexual intercourse. Score of ≤25 on the erectile function domain (IIEF-EF) of the IIEF at screening or at the baseline visit. * Evidence of hypogonadism. * Have a communicable skin or sexually-transmitted disease, or any rash or lesions on the penis or in the surrounding area (as reported by subject and evaluated by investigator). * Serum prostate-specific antigen (PSA) \>2.0 ng/mL at screening. * Serum creatinine \>1.5xULN at screening. * Unstable liver disease (chronic stable hepatitis B and C are acceptable if the subject otherwise meets entry criteria). * History of malignancy (including prostate cancer) within the past 5 years, except basal cell or squamous cell carcinoma of the skin. * History of prostate cancer before the age of 50 years in a first degree relative. * History of breast cancer or clinical breast examination suggestive of malignancy. * Any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to screening; and uncontrolled diabetes or peptic ulcer disease that is uncontrolled by medical management. * History or current evidence of any serious and/or unstable pre-existing medical or psychiatric disorder, or other conditions that could, in the opinion of the investigator or the medical monitor, interfere with the subject's safety, obtaining informed consent, or compliance with study procedures.Note: the investigator may consult with the GSK medical monitor if a condition could interfere with the subject's safety. * Global scalp hair thinning, including occipital areas. * Scarring of the scalp, including prior hair transplant or scalp reduction, or any other condition or disease of the scalp or hair, including diseases of the hair shaft (e.g., tinea infection, non-androgenetic-cause of alopecia, psoriatic dermatitis or other psoriatic lesions, or uncontrolled seborrheic dermatitis). * History of hair transplantation at any time to correct AGA or use of hair weaving within 6 months prior to screening. * History or evidence of hair loss other than AGA (e.g., due to an auto-immune, endocrine, mechanical or infectious process, or secondary to a scalp dermatological disorder). * Use of any cosmetic product aimed at improving or correcting the signs of hair loss (e.g., scalp preparations with claims aiming at improved hair growth) within 2 weeks prior to screening. * Use of light or laser treatments on the scalp (e.g., light emitting diode \[LED\] lamps) within 3 months prior to screening. * Hypersensitivity to any 5-alpha reductase inhibitor (5-ARI) or its components or excipients or drugs chemically related to the study treatment. * Use of dutasteride within 10 months prior to screening or use of finasteride within 6 months prior to screening. * Previous use of systemic cytotoxic agents. * Use of glucocorticoids (inhaled glucocorticoids are allowed; topical corticosteroids are allowed provided that they are not used on the scalp) within 3 months prior to screening. * Use of the following prior to Baseline (within 1 week for topical products; within 1 week or 5 half-lives, whichever is longer, for systemic treatments): Phosphodiesterase type 5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil); Minoxidil (oral or topical); Carpronium chloride; Systemic drugs with anti-androgenic properties (e.g., cyproterone acetate, spironolactone, ketoconazole, flutamide, and bicalutamide); Topical or systemic estrogen or progesterone; Drugs potentially causing hypertrichosis (e.g., cyclosporine, diazoxide, phenytoin, psoralens); Drugs potentially causing hypertrichosis or telogen effluvium (e.g., valproic acid); Anabolic steroids; * Participation in any study of an investigational or marketed drug (within 5 half lives of drug) or device that may affect hair growth or sexual function prior to screening for this study. Note: Subject must not participate in any other drug or device studies during the course of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AE) Related to Sexual Function in the Double-blind Treatment Period | 24 weeks | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. |
| Number of Participants With AE Related to Sexual Function in the Open-label Treatment Period | 24 weeks | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. |
| Number of Participants With AE Related to Sexual Function for the Double-blind and Open-label Combined Periods | 48 weeks | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Double-blind Treatment Period | 24 weeks | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. |
| Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Open-label Treatment Period | 24 weeks | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. |
| Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Double-blind and Open-label Combined Periods | 48 weeks | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. |
| Number of Participants With AEs, Serious AEs (SAEs) and Possible Suicidality Related Adverse Events (PSRAEs) in the Double-blind Treatment Period | 24 weeks | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment, all events of possible drug-induced liver injury with hyperbilirubinemia, breast cancer in male participants, or spontaneous abortion in female partner of male participant. The PSRAE form was used in this study to collect detailed information on the circumstances of reported AEs which, in the investigator's opinion, were possibly suicidality-related. |
| Number of Participants With AEs, SAEs and PSRAEs in the Open-label Treatment Period | 24 weeks | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.. SAE is defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment, all events of possible drug-induced liver injury with hyperbilirubinemia, breast cancer in male participants, or spontaneous abortion in female partner of male participant. The PSRAE form was used in this study to collect detailed information on the circumstances of reported AEs which, in the investigator's opinion, were possibly suicidality-related. |
| Number of Participants With AEs, SAEs and PSRAEs in the Double-blind and Open-label Combined Periods | 48 weeks | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.. SAE is defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment, all events of possible drug-induced liver injury with hyperbilirubinemia, breast cancer in male participants, or spontaneous abortion in female partner of male participant. The PSRAE form was used in this study to collect detailed information on the circumstances of reported AEs which, in the investigator's opinion, were possibly suicidality-related. |
| Number of Participants With Treatment-related AEs in the Double-blind Treatment Period | 24 weeks | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment related AE included events which the investigator classified as having a reasonable possibilty of being caused by the investigational product or whose classification was missing. |
| Number of Participants With Treatment-related AEs in the Open-label Treatment Period | 24 weeks | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment related AE included events which the investigator classified as having a reasonable possibilty of being caused by the investigational product or whose classification was missing. |
| Number of Participants With Treatment-related AEs in the Double-blind and Open-label Combined Periods | 48 weeks | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment related AE included events which the investigator classified as having a reasonable possibility of being caused by the investigational product or whose classification was missing. |
| Number of Participants With AEs of Special Interest in the Double-blind Treatment Period | 24 weeks | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs of special interest included those of sexual function: breast disorders (breast enlargement and breast tenderness), prostate cancer, cardiovascular events, and possible suicidality-related AEs (PSRAEs). Infrequent AEs of special interest included breast cancer, allergic reactions, depressed mood, hair changes, interference with formation of external genitalia in a male fetus, potential for decreased male fertility, and testicular pain and swelling. Special interest AEs are groups of MedDRA terms which have been defined in the analysis plan. |
| Number of Participants With AEs of Special Interest in the Open-label Treatment Period | 24 weeks | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs of special interest included those of sexual function: breast disorders (breast enlargement and breast tenderness), prostate cancer, cardiovascular events, and possible suicidality-related AEs (PSRAEs). Infrequent AEs of special interest included breast cancer, allergic reactions, depressed mood, hair changes, interference with formation of external genitalia in a male fetus, potential for decreased male fertility, and testicular pain and swelling. Special interest AEs are groups of MedDRA terms which have been defined in the analysis plan. |
| Number of Participants With AEs of Special Interest in the Double-blind and Open-label Combined Periods | 48 weeks | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs of special interest included those of sexual function: breast disorders (breast enlargement and breast tenderness), prostate cancer, cardiovascular events, and possible suicidality-related AEs (PSRAEs). Infrequent AEs of special interest included breast cancer, allergic reactions, depressed mood, hair changes, interference with formation of external genitalia in a male fetus, potential for decreased male fertility, and testicular pain and swelling. Special interest AEs are groups of MedDRA terms which have been defined in the analysis plan. |
| Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period | 24 weeks | Assessment of suicidality were done through use of the Columbia Suicide Severity Rating Scale (C-SSRS) for suicidal ideation with the ratings 1 to 5 (1. wish to be dead, 2. Non-specific suicidal thoughts, 3..without intent, 4. with intent but no plan, 5. with plan and intent) and for suicidal behavior with the ratings 6 to 9 (6.Prep acts/behavior, 7.aborted attempt, 8. interrupted attempt and 9. actual attempt). C-SSRS was administered at Day 1, Week 12, Week 24, and the early withdrawal visit if applicable . |
| Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period | 24 weeks | Assessment of suicidality were done through use of the Columbia Suicide Severity Rating Scale (C-SSRS) for suicidal ideation with the ratings 1 to 5 (1. wish to be dead, 2. Non-specific suicidal thoughts, 3. without intent, 4. with intent but no plan, 5. with plan and intent) and for suicidal behavior with the ratings 6 to 9 (6.Prep acts/behavior, 7.aborted attempt, 8. interrupted attempt and 9. actual attempt). C-SSRS was administered at Day 1, Week 12, Week 24, and the early withdrawal visit if applicable . |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in the Double-blind Treatment Period | Baseline, Week 12 and Week 24 | The Baseline blood presssure assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Change From Baseline in Systolic and Diastolic Blood Pressure in the Open-label Treatment Period | Baseline, Week 12 and Week 24 | Baseline blood presure assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Change From Baseline in Heart Rate in the Double-blind Treatment Period | Baseline, Week 12 and Week 24 | The Baseline heart rate assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Change From Baseline in Heart Rate in the Open-label Treatment Period | Baseline, Week 12 and Week 24 | Baseline heart rate assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period | Baseline and up to Week 24 | The Baseline blood presssure assessment was defined as the latest assessment on or before the double-blind treatment start. The clinical concern range for vital signs was defined as: Systolic blood pressure (lower: \<80, upper: \>165) and diastolic blood pressure: (lower: \<40, upper: \>105). |
| Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period | Baseline and up to Week 24 | The Baseline blood presssure assessment was defined as the latest assessment on or before the open-label treatment start. The clinical concern range for vital signs was defined as: systolic blood pressure (lower: \<80, upper: \>165) and diastolic blood pressure: (lower: \<40, upper: \>105). |
| Number of Participants With Frequency of Heart Rate of Clinical Concern in the Double-blind Treatment Period | Baseline and up to Week 24 | The Baseline heart rate assessment was defined as the latest assessment on or before the double-blind treatment start. The clinical concern range for heart rate was defined as: (lower: \<40, upper: \>100). |
| Number of Participants With Frequency of Heart Rate of Clinical Concern in the Open-label Treatment Period | Baseline and up to Week 24 | Baseline heart rate assessment was defined as the latest assessment on or before the open-label treatment start. The clinical concern range for heart rate was defined as: (lower: \<40, upper: \>100). |
| Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Baseline and up to Week 24 | Hematology parameters included: platelet count, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes, segmented neutrophils and total neutrophils at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Baseline and up to Week 24 | Hematology parameters included: platelet count, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes, segmented neutrophils, and total neutrophils at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Hematocrit | Baseline and up to Week 24 | Hematology parameter included: hematocrit at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Hematocrit | Baseline and up to Week 24 | Hematology parameter included: hematocrit at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Hemoglobin | Baseline and up to Week 24 | Hematology parameter included: hemoglobin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Hemoglobin | Baseline and up to Week 24 | Hematology parameters included: hemoglobin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Red Blood Cell (RBC) Count | Baseline and up to Week 24 | Hematology parameter included: RBC at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Red Blood Cell (RBC) Count | Baseline and up to Week 24 | Hematology parameter included: RBC at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Albumin and Total Protein | Baseline and up to Week 24 | Clinical chemistry parameters included: albumin and total protein at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Change From Baseline in Clinical Chemistry Parameters in the Open-label Treatment Period: Albumin and Total Protein | Baseline and up to Week 24 | Clinical chemistry parameters included: albumin and total protein at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period | Baseline and up to Week 24 | Clinical chemistry parameters included: alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST) and gamma glutamyl transferase (GGT) at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period | Baseline and up to Week 24 | Clinical chemistry parameters included: ALT, ALP, AST, and GGT at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin | Baseline and up to Week 24 | Clinical chemistry parameters included: creatinine, direct bilirubin, total bilirubin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Change From Baseline in the Clinical Chemistry Parameters in the Open-label Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin. | Baseline and up to Week 24 | Clinical chemistry parameters included: creatinine, direct bilirubin, total bilirubin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Baseline and up to Week 24 | Clinical chemistry parameters included: glucose, potassium, sodium, and urea/BUN at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period: Glucose, Potassium, Sodium and Urea/BUN. | Baseline and up to Week 24 | Clinical chemistry parameters included: glucose, potassium, sodium, and urea/BUN at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Incidence of Premature Discontinuations in the Double-blind Treatment Period | Week 24 | Participants were referred as premature discontinuations if they do not complete the double-blind period. The reasons for premature withdrawal were protocol deviation, lost to follow-up and withdrawal of consent by participants. |
| Incidence of Premature Discontinuations in the Open-label Treatment Period | Week 48 | Participants were referred as premature discontinuations if they do not complete the open-label treatment period. The reasons for premature withdrawal were protocol deviation, lost to follow-up and withdrawal of consent by participants. |
| Number of Participants With a Change in Sexual Function Defined as a Negative Change From Baseline in the International Index of Erectile Function (IIEF) Erectile Function Domain (IIEF-EF) Score of >=4 Units in the Double-blind Treatment Period | Baseline, Week 4, Week 12 and Week 24 | The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. The erectile function domain of the IIEF (IIEF-EF) includes Questions 1 through 5 and Question 15 (maximum score of 30). A clinically meaningful gradient of severity of erectile dysfunction (ED) has been developed, indicating that a score of greater than 25 represents an individual without ED while men scoring \<=25 may be classified as having ED. The values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. |
| Number of Participants With a Change in Sexual Function Defined as a Negative Change From Baseline in the IIEF Erectile Function Domain (IIEF-EF) Score of >=4 Units in the Open-label Treatment Period | Baseline, Week 4, Week 12 and Week 24 | The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. The erectile function domain of the IIEF (IIEF-EF) includes Questions 1 through 5 and Question 15 (maximum score of 30). A clinically meaningful gradient of severity of erectile dysfunction (ED) has been developed, indicating that a score of greater than 25 represents an individual without ED while men scoring \<=25 may be classified as having ED. The values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. |
| Change From Baseline in Total Score of the IIEF in the Double-blind Treatment Period | Baseline, Week 4, Week 12 and Week 24 | The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The change from Baseline values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Change From Baseline in Total Score of the IIEF in the Open-label Treatment Period | Baseline, Week 4, Week 12 and Week 24 | The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The change from Baseline values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Baseline, Week 4, Week 12 and Week 24 | The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Baseline, Week 4, Week 12 and Week 24 | The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The Baseline assessment was defined as the latest assessment on or before the OL treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Change From Baseline in Participant Satisfaction With Hair Growth as Assessed by the Total Score of the Hair Growth Satisfaction Scale (HGSS) in the Double-blind Treatment Period | Baseline, Week 12 and Week 24 | The HGSS assessed participants satisfaction with hair appearance and growth by scoring 5 questions on a 7-point scale ranging from 1=very dissatisfied to 7= very satisfied with a maximum score of 35. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. A decrease from Baseline indicates a worsening. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Duration and Persistence of AEs Related to Sexual Function in the Double-blind Treatment Period | 24 weeks | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. Duration is the total number of non-overlapping days for all events per subject. A duration is censored if there is at least one event with unknown start date or end date, in which case the censored duration is the minimum number of days that a subject has experienced any of these events. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA=not applicable. |
| Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) in the Double-blind Treatment Period | Baseline, Week 12 and Week 24 | The DLQI was a 10-item questionnaire designed to evaluate the effect of skin conditions (alopecia) on the participants quality of life. Each item was scored on a 4-point scale ranging from 0 to 3 with a maximum score of 30. Higher scores represent greater impairment in quality of life. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Change From Baseline in the Total Score of the DLQI in the Open-label Treatment Period | Baseline and Upto Week 24 | The DLQI was a 10-item questionnaire designed to evaluate the effect of skin conditions (alopecia) on the participants quality of life. Each item was scored on a 4-point scale ranging from 0 to 3 with a maximum score of 30. Higher scores represent greater impairment in quality of life. The Baseline assessment was defined as the latest assessment on or before the OL treatment start. Change from Baseline is post-Baseline value minus Baseline value. |
| Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline and up to Week 24 | The global assessment questions consist of 2 questions, recording how much the participant perceives his sexual life has changed and how he perceives his ability to achieve and maintain erections has changed, compared to how it was before he began receiving treatment in this study. The wording of these questions were based on the Patient Global Impression of Improvement questionnaire, which was validated for use in the assessment of improvement in stress urinary incontinence. The questions were scored on a 7-point scale.The Baseline assessment was defined as the latest assessment on or before the DB treatment start. |
| Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | Baseline and up to Week 24 | The global assessment questions consist of 2 questions, recording how much the participant perceives his sexual life has changed and how he perceives his ability to achieve and maintain erections has changed, compared to how it was before he began receiving treatment in this study. The wording of these questions were based on the Patient Global Impression of Improvement questionnaire, which was validated for use in the assessment of improvement in stress urinary incontinence. The questions were scored on a 7-point scale.The Baseline assessment was defined as the latest assessment on or before the OL treatment start. |
| Change From Baseline in Participant Satisfaction With Hair Growth as Assessed by the Total Score of the HGSS in the Open-label Treatment Period | Baseline and up to Week 24 | The HGSS assessed participants satisfaction with hair appearance and growth by scoring 5 questions on a 7-point scale ranging from 1=very dissatisfied to 7=very satisfied with a maximum score of 35. The Baseline assessment was defined as the latest assessment on or before the OL treatment start. Change from Baseline is post-Baseline value minus Baseline value. A decrease from Baseline indicates a worsening. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
| Duration and Persistence of AEs Related to Sexual Function in the Open-label Treatment Period | 24 weeks | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. Duration is the total number of non-overlapping days for all events per subject. A duration is censored if there is at least one event with unknown start date or end date, in which case the censored duration is the minimum number of days that a subject has experienced any of these events. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA=not applicable. |
| Duration and Persistence of AEs Related to Sexual Function in the Double-blind and Open-label Combined Periods | 48 weeks | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. Duration is the total number of non-overlapping days for all events per subject. A duration is censored if there is at least one event with unknown start date or end date, in which case the censored duration is the minimum number of days that a subject has experienced any of these events. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA=not applicable. |
Countries
Chile, Hong Kong, Singapore, South Korea, Taiwan
Participant flow
Recruitment details
The study consisted of a Screening Visit, a 4-week Placebo Run-in Period, a 24-week Double-Blind (DB) Treatment Period, followed by a 24-week Open-Label (OL) Active Treatment Period, and a 4-week post-treatment Follow-Up Visit.
Pre-assignment details
Participants with an ongoing AE related to sexual function at the end of the treatment Period and participants who discontinued study treatment due to an AE related to sexual function entered a Targeted Follow-Up Period lasting until 24 weeks after the last dose of study treatment or until resolution of the sexual AE, whichever occurred first.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo administered orally once daily for 24 weeks. | 59 |
| Dutasteride 0.5 mg Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. | 58 |
| Total | 117 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Double-Blind Period (24 Weeks) | Protocol Violation | 0 | 1 | 0 | 0 | 0 | 0 |
| Double-Blind Period (24 Weeks) | Withdrawal by Subject | 2 | 5 | 0 | 0 | 0 | 0 |
| Open-Label Period (24 Weeks) | Lost to Follow-up | 0 | 0 | 2 | 0 | 0 | 0 |
| Open-Label Period (24 Weeks) | Withdrawal by Subject | 0 | 0 | 3 | 1 | 0 | 0 |
| Target Follow-up (F/U) Period (24 Weeks) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Dutasteride 0.5 mg | Total |
|---|---|---|---|
| Age, Continuous | 39.0 Years STANDARD_DEVIATION 6.77 | 39.1 Years STANDARD_DEVIATION 6.65 | 39.0 Years STANDARD_DEVIATION 6.68 |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 49 Participants | 48 Participants | 97 Participants |
| Race/Ethnicity, Customized Asian - Southeast Asian Heritage | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 59 Participants | 58 Participants | 117 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 59 | 10 / 58 | 1 / 49 | 4 / 48 | 13 / 48 |
| serious Total, serious adverse events | 1 / 59 | 1 / 58 | 1 / 49 | 0 / 48 | 1 / 48 |
Outcome results
Primary
Number of Participants With Adverse Events (AE) Related to Sexual Function in the Double-blind Treatment Period
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.
Time frame: 24 weeks
Population: Safety Population: all randomized participants who received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Adverse Events (AE) Related to Sexual Function in the Double-blind Treatment Period | 5 Participants |
| Dutasteride 0.5 mg | Number of Participants With Adverse Events (AE) Related to Sexual Function in the Double-blind Treatment Period | 9 Participants |
p-value: 0.2795% CI: [-4.7, 18.8]Fisher's Exact Test
Primary
Number of Participants With AE Related to Sexual Function for the Double-blind and Open-label Combined Periods
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.
Time frame: 48 weeks
Population: Dutasteride DB/OL Combined: all participants who entered the OL Period and taken Dutasteride in both the DB and the OL periods.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With AE Related to Sexual Function for the Double-blind and Open-label Combined Periods | 10 Participants |
Primary
Number of Participants With AE Related to Sexual Function in the Open-label Treatment Period
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.
Time frame: 24 weeks
Population: Open-Label Period Population: all participants who entered the open-label period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With AE Related to Sexual Function in the Open-label Treatment Period | 3 Participants |
| Dutasteride 0.5 mg | Number of Participants With AE Related to Sexual Function in the Open-label Treatment Period | 2 Participants |
Secondary
Change From Baseline in Clinical Chemistry Parameters in the Open-label Treatment Period: Albumin and Total Protein
Clinical chemistry parameters included: albumin and total protein at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline and up to Week 24
Population: Open-Label Period Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Chemistry Parameters in the Open-label Treatment Period: Albumin and Total Protein | Albumin OL Week 24, n=44, 47 | -0.6 G/L | Standard Deviation 2.02 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters in the Open-label Treatment Period: Albumin and Total Protein | Albumin Final Value, n=44, 47 | -0.5 G/L | Standard Deviation 2.05 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters in the Open-label Treatment Period: Albumin and Total Protein | Total Protein OL Week 24, n=44, 47 | -0.8 G/L | Standard Deviation 3.9 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters in the Open-label Treatment Period: Albumin and Total Protein | Total Protein Final Value, n=44, 47 | -0.7 G/L | Standard Deviation 3.94 |
| Dutasteride 0.5 mg | Change From Baseline in Clinical Chemistry Parameters in the Open-label Treatment Period: Albumin and Total Protein | Total Protein Final Value, n=44, 47 | -2.4 G/L | Standard Deviation 3.23 |
| Dutasteride 0.5 mg | Change From Baseline in Clinical Chemistry Parameters in the Open-label Treatment Period: Albumin and Total Protein | Albumin OL Week 24, n=44, 47 | -1.1 G/L | Standard Deviation 2.02 |
| Dutasteride 0.5 mg | Change From Baseline in Clinical Chemistry Parameters in the Open-label Treatment Period: Albumin and Total Protein | Total Protein OL Week 24, n=44, 47 | -2.4 G/L | Standard Deviation 3.23 |
| Dutasteride 0.5 mg | Change From Baseline in Clinical Chemistry Parameters in the Open-label Treatment Period: Albumin and Total Protein | Albumin Final Value, n=44, 47 | -1.1 G/L | Standard Deviation 2.02 |
Secondary
Change From Baseline in Heart Rate in the Double-blind Treatment Period
The Baseline heart rate assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline, Week 12 and Week 24
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Heart Rate in the Double-blind Treatment Period | Week 12, n=59, 53 | 0.3 Beats per Minute | Standard Deviation 8.19 |
| Placebo | Change From Baseline in Heart Rate in the Double-blind Treatment Period | Week 24, n=57, 52 | 0.6 Beats per Minute | Standard Deviation 9.21 |
| Dutasteride 0.5 mg | Change From Baseline in Heart Rate in the Double-blind Treatment Period | Week 12, n=59, 53 | -0.6 Beats per Minute | Standard Deviation 11.39 |
| Dutasteride 0.5 mg | Change From Baseline in Heart Rate in the Double-blind Treatment Period | Week 24, n=57, 52 | -0.7 Beats per Minute | Standard Deviation 11.2 |
Secondary
Change From Baseline in Heart Rate in the Open-label Treatment Period
Baseline heart rate assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline, Week 12 and Week 24
Population: Open-Label Period Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Heart Rate in the Open-label Treatment Period | Week 12, n=46, 48 | -1.5 Beats per Minute | Standard Deviation 10.86 |
| Placebo | Change From Baseline in Heart Rate in the Open-label Treatment Period | Week 24, n=44, 47 | -0.3 Beats per Minute | Standard Deviation 10.83 |
| Dutasteride 0.5 mg | Change From Baseline in Heart Rate in the Open-label Treatment Period | Week 12, n=46, 48 | 1.1 Beats per Minute | Standard Deviation 13.15 |
| Dutasteride 0.5 mg | Change From Baseline in Heart Rate in the Open-label Treatment Period | Week 24, n=44, 47 | 1.2 Beats per Minute | Standard Deviation 11.26 |
Secondary
Change From Baseline in Participant Satisfaction With Hair Growth as Assessed by the Total Score of the Hair Growth Satisfaction Scale (HGSS) in the Double-blind Treatment Period
The HGSS assessed participants satisfaction with hair appearance and growth by scoring 5 questions on a 7-point scale ranging from 1=very dissatisfied to 7= very satisfied with a maximum score of 35. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. A decrease from Baseline indicates a worsening. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline, Week 12 and Week 24
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Participant Satisfaction With Hair Growth as Assessed by the Total Score of the Hair Growth Satisfaction Scale (HGSS) in the Double-blind Treatment Period | DB Week 12, n= 58, 53 | 1.3 Scores on a Scale | Standard Error 0.79 |
| Placebo | Change From Baseline in Participant Satisfaction With Hair Growth as Assessed by the Total Score of the Hair Growth Satisfaction Scale (HGSS) in the Double-blind Treatment Period | DB Week 24, n=57, 52 | -0.1 Scores on a Scale | Standard Error 0.79 |
| Dutasteride 0.5 mg | Change From Baseline in Participant Satisfaction With Hair Growth as Assessed by the Total Score of the Hair Growth Satisfaction Scale (HGSS) in the Double-blind Treatment Period | DB Week 12, n= 58, 53 | 2.4 Scores on a Scale | Standard Error 0.82 |
| Dutasteride 0.5 mg | Change From Baseline in Participant Satisfaction With Hair Growth as Assessed by the Total Score of the Hair Growth Satisfaction Scale (HGSS) in the Double-blind Treatment Period | DB Week 24, n=57, 52 | 3.2 Scores on a Scale | Standard Error 0.82 |
p-value: 0.3395% CI: [-1.1, 3.4]t-test from general linear model
p-value: 0.00495% CI: [1.1, 5.6]t-test from general linear model
Secondary
Change From Baseline in Participant Satisfaction With Hair Growth as Assessed by the Total Score of the HGSS in the Open-label Treatment Period
The HGSS assessed participants satisfaction with hair appearance and growth by scoring 5 questions on a 7-point scale ranging from 1=very dissatisfied to 7=very satisfied with a maximum score of 35. The Baseline assessment was defined as the latest assessment on or before the OL treatment start. Change from Baseline is post-Baseline value minus Baseline value. A decrease from Baseline indicates a worsening. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline and up to Week 24
Population: Open-label Period Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Participant Satisfaction With Hair Growth as Assessed by the Total Score of the HGSS in the Open-label Treatment Period | 4.5 Scores on a Scale | Standard Deviation 6.96 |
| Dutasteride 0.5 mg | Change From Baseline in Participant Satisfaction With Hair Growth as Assessed by the Total Score of the HGSS in the Open-label Treatment Period | 4.5 Scores on a Scale | Standard Deviation 7.23 |
Secondary
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period
The global assessment questions consist of 2 questions, recording how much the participant perceives his sexual life has changed and how he perceives his ability to achieve and maintain erections has changed, compared to how it was before he began receiving treatment in this study. The wording of these questions were based on the Patient Global Impression of Improvement questionnaire, which was validated for use in the assessment of improvement in stress urinary incontinence. The questions were scored on a 7-point scale.The Baseline assessment was defined as the latest assessment on or before the DB treatment start.
Time frame: Baseline and up to Week 24
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, Erection ability, Very Much Better | 1 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, Erection ability, Very Much Worse | 0 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, Erection ability, Much Better | 0 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, sexual life, Much Better | 1 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, Erection ability, A Little Better | 2 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, Sexual life, Very Much Better | 0 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, Erection ability, No change | 49 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, Erection ability, No change | 54 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, Erection ability, A Little Worse | 5 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, sexual life, A Little Better | 1 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, Erection ability, Much worse | 0 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, Erection ability, Much Better | 1 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, Erection ability, Very Much Worse | 0 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, sexual life, No change | 55 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, Sexual life, Very Much Better | 1 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, Erection ability, A Little Worse | 3 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, sexual life, Much Better | 0 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, sexual life, A Little Worse | 2 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, sexual life, A Little Better | 3 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, Erection ability, Very Much Better | 0 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, sexual life, No change | 47 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, sexual life, Much worse | 0 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, sexual life, A Little Worse | 6 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, Erection ability, Much worse | 0 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, sexual life, Much worse | 0 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, sexual life, Very Much Worse | 0 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, sexual life, Very Much Worse | 0 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, Erection ability, A Little Better | 1 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, sexual life, Very Much Worse | 0 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, Erection ability, Very Much Better | 0 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, Erection ability, Much Better | 1 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, Erection ability, A Little Better | 1 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, Erection ability, No change | 55 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, Erection ability, A Little Worse | 1 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, Erection ability, Much worse | 0 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, Erection ability, Very Much Worse | 0 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, sexual life, Much Better | 1 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, sexual life, A Little Better | 0 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, sexual life, No change | 56 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, sexual life, A Little Worse | 1 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, sexual life, Much worse | 0 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, sexual life, Very Much Worse | 0 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, Erection ability, Very Much Better | 0 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, Erection ability, Much Better | 0 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, Erection ability, A Little Better | 4 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, Erection ability, No change | 40 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, Erection ability, A Little Worse | 7 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, Erection ability, Much worse | 1 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, Erection ability, Very Much Worse | 0 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, Sexual life, Very Much Better | 0 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, sexual life, Much Better | 1 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, sexual life, A Little Better | 2 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, sexual life, No change | 39 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, sexual life, A Little Worse | 9 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | DB week 24, sexual life, Much worse | 1 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period | Baseline, Sexual life, Very Much Better | 0 Participants |
Secondary
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period
The global assessment questions consist of 2 questions, recording how much the participant perceives his sexual life has changed and how he perceives his ability to achieve and maintain erections has changed, compared to how it was before he began receiving treatment in this study. The wording of these questions were based on the Patient Global Impression of Improvement questionnaire, which was validated for use in the assessment of improvement in stress urinary incontinence. The questions were scored on a 7-point scale.The Baseline assessment was defined as the latest assessment on or before the OL treatment start.
Time frame: Baseline and up to Week 24
Population: open-label period population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, Erection ability, Very Much Better | 0 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, Erection ability, A Little Worse | 5 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, Erection ability, Much Better | 2 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, sexual life, Much Better | 0 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, Erection ability, A Little Better | 1 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, Erection ability, Much Better | 0 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, Erection ability, No change | 35 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, sexual life, A Little Better | 2 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, Erection ability, A Little Worse | 6 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, Erection ability, Much worse | 0 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, Erection ability, Much worse | 0 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, sexual life, No change | 40 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, Erection ability, Very Much Worse | 0 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, Erection ability, No change | 42 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, Sexual life, Very Much Better | 0 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, sexual life, A Little Worse | 6 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, sexual life, Much Better | 2 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, Erection ability, Very Much Worse | 0 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, sexual life, A Little Better | 1 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, sexual life, Much worse | 0 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, sexual life, No change | 37 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, Erection ability, A Little Better | 1 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, sexual life, A Little Worse | 4 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, sexual life, Very Much Worse | 0 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, sexual life, Much worse | 0 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, Sexual life, Very Much Better | 1 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, sexual life, Very Much Worse | 0 Participants |
| Placebo | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, Erection ability, Very Much Better | 1 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, sexual life, Very Much Worse | 0 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, Erection ability, Very Much Better | 0 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, Erection ability, Much Better | 0 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, Erection ability, A Little Better | 4 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, Erection ability, No change | 39 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, Erection ability, A Little Worse | 5 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, Erection ability, Much worse | 0 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, Erection ability, Very Much Worse | 0 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, Sexual life, Very Much Better | 0 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, sexual life, Much Better | 1 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, sexual life, A Little Better | 2 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, sexual life, No change | 39 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, sexual life, A Little Worse | 6 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, sexual life, Much worse | 0 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL Baseline, sexual life, Very Much Worse | 0 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, Erection ability, Very Much Better | 0 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, Erection ability, Much Better | 0 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, Erection ability, A Little Better | 4 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, Erection ability, No change | 37 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, Erection ability, A Little Worse | 5 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, Erection ability, Much worse | 0 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, Erection ability, Very Much Worse | 0 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, Sexual life, Very Much Better | 0 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, sexual life, Much Better | 1 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, sexual life, A Little Better | 2 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, sexual life, No change | 39 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, sexual life, A Little Worse | 4 Participants |
| Dutasteride 0.5 mg | Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period | OL week 24, sexual life, Much worse | 0 Participants |
Secondary
Change From Baseline in Systolic and Diastolic Blood Pressure in the Open-label Treatment Period
Baseline blood presure assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline, Week 12 and Week 24
Population: Open-Label Period Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Systolic and Diastolic Blood Pressure in the Open-label Treatment Period | SBP Week 12, n=46, 48 | -0.9 mmHg | Standard Deviation 10.02 |
| Placebo | Change From Baseline in Systolic and Diastolic Blood Pressure in the Open-label Treatment Period | SBP Week 24, n=44, 47 | -0.7 mmHg | Standard Deviation 11.3 |
| Placebo | Change From Baseline in Systolic and Diastolic Blood Pressure in the Open-label Treatment Period | DBP Week 12, n=46, 48 | -0.8 mmHg | Standard Deviation 8.87 |
| Placebo | Change From Baseline in Systolic and Diastolic Blood Pressure in the Open-label Treatment Period | DBP Week 24, n=44, 47 | -1.4 mmHg | Standard Deviation 8.26 |
| Dutasteride 0.5 mg | Change From Baseline in Systolic and Diastolic Blood Pressure in the Open-label Treatment Period | DBP Week 24, n=44, 47 | 0.9 mmHg | Standard Deviation 11.23 |
| Dutasteride 0.5 mg | Change From Baseline in Systolic and Diastolic Blood Pressure in the Open-label Treatment Period | SBP Week 12, n=46, 48 | 0.1 mmHg | Standard Deviation 12.76 |
| Dutasteride 0.5 mg | Change From Baseline in Systolic and Diastolic Blood Pressure in the Open-label Treatment Period | DBP Week 12, n=46, 48 | -0.6 mmHg | Standard Deviation 9 |
| Dutasteride 0.5 mg | Change From Baseline in Systolic and Diastolic Blood Pressure in the Open-label Treatment Period | SBP Week 24, n=44, 47 | 0.4 mmHg | Standard Deviation 12.9 |
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in the Double-blind Treatment Period
The Baseline blood presssure assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline, Week 12 and Week 24
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in the Double-blind Treatment Period | SBP Week 12, n=59, 53 | 0.9 millimeter of mercury (mmHg) | Standard Deviation 9.71 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in the Double-blind Treatment Period | SBP Week 24, n=57, 52 | -1.0 millimeter of mercury (mmHg) | Standard Deviation 13.27 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in the Double-blind Treatment Period | DBP Week 12, n=59, 53 | 2.1 millimeter of mercury (mmHg) | Standard Deviation 7.99 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in the Double-blind Treatment Period | DBP Week 24, n=57, 52 | -0.2 millimeter of mercury (mmHg) | Standard Deviation 9.78 |
| Dutasteride 0.5 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in the Double-blind Treatment Period | DBP Week 24, n=57, 52 | -1.5 millimeter of mercury (mmHg) | Standard Deviation 9.73 |
| Dutasteride 0.5 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in the Double-blind Treatment Period | SBP Week 12, n=59, 53 | -0.1 millimeter of mercury (mmHg) | Standard Deviation 10.46 |
| Dutasteride 0.5 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in the Double-blind Treatment Period | DBP Week 12, n=59, 53 | 1.6 millimeter of mercury (mmHg) | Standard Deviation 9.23 |
| Dutasteride 0.5 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in the Double-blind Treatment Period | SBP Week 24, n=57, 52 | -2.0 millimeter of mercury (mmHg) | Standard Deviation 14.08 |
Secondary
Change From Baseline in the Clinical Chemistry Parameters in the Open-label Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin.
Clinical chemistry parameters included: creatinine, direct bilirubin, total bilirubin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline and up to Week 24
Population: Open-Label Period Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Clinical Chemistry Parameters in the Open-label Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin. | Creatinine OL Week 24, n=44, 47 | 1.1 UMOL/L | Standard Deviation 12.01 |
| Placebo | Change From Baseline in the Clinical Chemistry Parameters in the Open-label Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin. | Creatinine Final Value, n=44, 47 | 1.2 UMOL/L | Standard Deviation 12.01 |
| Placebo | Change From Baseline in the Clinical Chemistry Parameters in the Open-label Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin. | Direct bilirubin OL Week 24, n=44, 47 | 0.1 UMOL/L | Standard Deviation 0.89 |
| Placebo | Change From Baseline in the Clinical Chemistry Parameters in the Open-label Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin. | Direct bilirubin Final Value, n=44, 47 | 0.1 UMOL/L | Standard Deviation 0.9 |
| Placebo | Change From Baseline in the Clinical Chemistry Parameters in the Open-label Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin. | Total bilirubin OL Week 24, n=44, 47 | 0.9 UMOL/L | Standard Deviation 3.84 |
| Placebo | Change From Baseline in the Clinical Chemistry Parameters in the Open-label Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin. | Total bilirubin Final Value, n=44, 47 | 1.0 UMOL/L | Standard Deviation 3.91 |
| Dutasteride 0.5 mg | Change From Baseline in the Clinical Chemistry Parameters in the Open-label Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin. | Total bilirubin OL Week 24, n=44, 47 | 0.4 UMOL/L | Standard Deviation 5.1 |
| Dutasteride 0.5 mg | Change From Baseline in the Clinical Chemistry Parameters in the Open-label Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin. | Creatinine OL Week 24, n=44, 47 | -0.2 UMOL/L | Standard Deviation 6.66 |
| Dutasteride 0.5 mg | Change From Baseline in the Clinical Chemistry Parameters in the Open-label Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin. | Direct bilirubin Final Value, n=44, 47 | 0.1 UMOL/L | Standard Deviation 1.02 |
| Dutasteride 0.5 mg | Change From Baseline in the Clinical Chemistry Parameters in the Open-label Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin. | Creatinine Final Value, n=44, 47 | -0.2 UMOL/L | Standard Deviation 6.66 |
| Dutasteride 0.5 mg | Change From Baseline in the Clinical Chemistry Parameters in the Open-label Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin. | Total bilirubin Final Value, n=44, 47 | 0.4 UMOL/L | Standard Deviation 5.1 |
| Dutasteride 0.5 mg | Change From Baseline in the Clinical Chemistry Parameters in the Open-label Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin. | Direct bilirubin OL Week 24, n=44, 47 | 0.1 UMOL/L | Standard Deviation 1.02 |
Secondary
Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period
Clinical chemistry parameters included: alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST) and gamma glutamyl transferase (GGT) at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline and up to Week 24
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period | ALT DB Week 24, n=57, 52 | 0.9 IU/L | Standard Deviation 21.69 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period | ALT Final Value, n=58, 53 | 1.0 IU/L | Standard Deviation 21.51 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period | ALP DB Week 24, n=57, 52 | -4.8 IU/L | Standard Deviation 10.41 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period | ALP Final Value, n=58, 53 | -4.8 IU/L | Standard Deviation 10.35 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period | AST DB Week 24, n=57, 51 | 0.7 IU/L | Standard Deviation 10.42 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period | AST Final Value, n=58, 52 | 0.6 IU/L | Standard Deviation 10.34 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period | GGT DB Week 24, n=57, 52 | -6.4 IU/L | Standard Deviation 30.95 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period | GGT Final Value, n=58, 53 | -6.3 IU/L | Standard Deviation 30.69 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period | GGT Final Value, n=58, 53 | -1.1 IU/L | Standard Deviation 15.67 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period | ALT DB Week 24, n=57, 52 | 4.0 IU/L | Standard Deviation 12.7 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period | AST DB Week 24, n=57, 51 | 0.5 IU/L | Standard Deviation 6.99 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period | ALT Final Value, n=58, 53 | 3.5 IU/L | Standard Deviation 12.37 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period | GGT DB Week 24, n=57, 52 | -1.1 IU/L | Standard Deviation 15.84 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period | ALP DB Week 24, n=57, 52 | -4.1 IU/L | Standard Deviation 8.16 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period | AST Final Value, n=58, 52 | 0.3 IU/L | Standard Deviation 6.65 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period | ALP Final Value, n=58, 53 | -4.5 IU/L | Standard Deviation 8.82 |
Secondary
Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Albumin and Total Protein
Clinical chemistry parameters included: albumin and total protein at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline and up to Week 24
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Albumin and Total Protein | Albumin, DB Week 24, n=57, 52 | 0.2 G/L | Standard Deviation 1.82 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Albumin and Total Protein | Albumin, Final Value, n=58, 53 | 0.2 G/L | Standard Deviation 1.81 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Albumin and Total Protein | Total Protein, DB Week 24, n=57, 52 | -0.1 G/L | Standard Deviation 3.14 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Albumin and Total Protein | Total Protein, Final Value, n=58, 53 | -0.1 G/L | Standard Deviation 3.09 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Albumin and Total Protein | Total Protein, Final Value, n=58, 53 | 0.1 G/L | Standard Deviation 3.79 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Albumin and Total Protein | Albumin, DB Week 24, n=57, 52 | -0.1 G/L | Standard Deviation 2.15 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Albumin and Total Protein | Total Protein, DB Week 24, n=57, 52 | -0.0 G/L | Standard Deviation 3.64 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Albumin and Total Protein | Albumin, Final Value, n=58, 53 | -0.1 G/L | Standard Deviation 2.21 |
Secondary
Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin
Clinical chemistry parameters included: creatinine, direct bilirubin, total bilirubin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline and up to Week 24
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin | Creatinine DB Week 24, n=57, 52 | 1.7 UMOL/L | Standard Deviation 8.2 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin | Creatinine Final Value, n=58, 53 | 1.6 UMOL/L | Standard Deviation 8.12 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin | Direct bilirubin DB Week 24, n=57, 52 | -0.2 UMOL/L | Standard Deviation 0.86 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin | Direct bilirubin Final Value, n=58, 53 | -0.1 UMOL/L | Standard Deviation 0.9 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin | Total bilirubin DB Week 24, n=57, 52 | -1.1 UMOL/L | Standard Deviation 4.66 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin | Total bilirubin Final Value, n=58, 53 | -1.1 UMOL/L | Standard Deviation 4.65 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin | Total bilirubin DB Week 24, n=57, 52 | -1.1 UMOL/L | Standard Deviation 4.56 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin | Creatinine DB Week 24, n=57, 52 | -0.7 UMOL/L | Standard Deviation 9.41 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin | Direct bilirubin Final Value, n=58, 53 | -0.2 UMOL/L | Standard Deviation 0.93 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin | Creatinine Final Value, n=58, 53 | -0.8 UMOL/L | Standard Deviation 9.37 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin | Total bilirubin Final Value, n=58, 53 | -1.0 UMOL/L | Standard Deviation 4.36 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin | Direct bilirubin DB Week 24, n=57, 52 | -0.3 UMOL/L | Standard Deviation 0.93 |
Secondary
Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN)
Clinical chemistry parameters included: glucose, potassium, sodium, and urea/BUN at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline and up to Week 24
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose DB Week 24, n=57, 52 | 0.1 MMOL/L | Standard Deviation 1.58 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose Final Value, n=58, 53 | 0.1 MMOL/L | Standard Deviation 1.57 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium DB Week 24, n=57, 51 | 0.0 MMOL/L | Standard Deviation 0.32 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium Final Value n=58, 52 | 0.0 MMOL/L | Standard Deviation 0.32 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium DB Week 24, n=57, 52 | 0.5 MMOL/L | Standard Deviation 1.6 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium Final Value, n=58, 53 | 0.5 MMOL/L | Standard Deviation 1.61 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN Final Value, n=57, 52 | 0.2 MMOL/L | Standard Deviation 1.22 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN Value, n=58, 53 | 0.2 MMOL/L | Standard Deviation 1.23 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN Value, n=58, 53 | 0.1 MMOL/L | Standard Deviation 1.33 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose DB Week 24, n=57, 52 | 0.0 MMOL/L | Standard Deviation 0.36 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium DB Week 24, n=57, 52 | 0.2 MMOL/L | Standard Deviation 2.13 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose Final Value, n=58, 53 | 0.0 MMOL/L | Standard Deviation 1.18 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN Final Value, n=57, 52 | 0.0 MMOL/L | Standard Deviation 1.32 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium DB Week 24, n=57, 51 | 0.0 MMOL/L | Standard Deviation 0.29 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium Final Value, n=58, 53 | 0.4 MMOL/L | Standard Deviation 1.87 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium Final Value n=58, 52 | 0.0 MMOL/L | Standard Deviation 0.3 |
Secondary
Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period
Clinical chemistry parameters included: ALT, ALP, AST, and GGT at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline and up to Week 24
Population: Open-Label Period Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period | ALT OL Week 24, n=44, 47 | -1.4 IU/L | Standard Deviation 19.22 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period | ALT Final Value, n=44, 47 | -1.3 IU/L | Standard Deviation 19.25 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period | ALP OL Week 24, n=44, 47 | 0.0 IU/L | Standard Deviation 9.87 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period | ALP Final Value, n=44, 47 | 0.0 IU/L | Standard Deviation 9.85 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period | AST OL Week 24, n=43, 47 | -0.2 IU/L | Standard Deviation 7 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period | AST Final Value, n=44, 47 | -0.5 IU/L | Standard Deviation 7.18 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period | GGT OL Week 24, n=44, 47 | 3.7 IU/L | Standard Deviation 13.13 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period | GGT Final Value, n=44, 47 | 3.7 IU/L | Standard Deviation 13.13 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period | GGT Final Value, n=44, 47 | 0.6 IU/L | Standard Deviation 19.59 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period | ALT OL Week 24, n=44, 47 | -1.7 IU/L | Standard Deviation 13.07 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period | AST OL Week 24, n=43, 47 | 0.1 IU/L | Standard Deviation 8.9 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period | ALT Final Value, n=44, 47 | -1.7 IU/L | Standard Deviation 13.07 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period | GGT OL Week 24, n=44, 47 | 0.6 IU/L | Standard Deviation 19.59 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period | ALP OL Week 24, n=44, 47 | -3.3 IU/L | Standard Deviation 7.59 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period | AST Final Value, n=44, 47 | 0.1 IU/L | Standard Deviation 8.9 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period | ALP Final Value, n=44, 47 | -3.3 IU/L | Standard Deviation 7.59 |
Secondary
Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period: Glucose, Potassium, Sodium and Urea/BUN.
Clinical chemistry parameters included: glucose, potassium, sodium, and urea/BUN at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline and up to Week 24
Population: Open-Label Period Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period: Glucose, Potassium, Sodium and Urea/BUN. | Glucose OL Week 24, n=44, 47 | 0.3 MMOL/L | Standard Deviation 1.48 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period: Glucose, Potassium, Sodium and Urea/BUN. | Glucose Final Value, n=44, 47 | 0.3 MMOL/L | Standard Deviation 1.48 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period: Glucose, Potassium, Sodium and Urea/BUN. | Potassium OL Week 24, n=43, 47 | -0.1 MMOL/L | Standard Deviation 0.36 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period: Glucose, Potassium, Sodium and Urea/BUN. | Potassium Final Value, n=44, 47 | -0.0 MMOL/L | Standard Deviation 0.37 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period: Glucose, Potassium, Sodium and Urea/BUN. | Sodium OL Week 24, n=44, 47 | -0.9 MMOL/L | Standard Deviation 2.51 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period: Glucose, Potassium, Sodium and Urea/BUN. | Sodium Final Value, n=44, 47 | -0.9 MMOL/L | Standard Deviation 2.51 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period: Glucose, Potassium, Sodium and Urea/BUN. | Urea/BUN OL Week 24, n=44, 47 | 0.3 MMOL/L | Standard Deviation 1.5 |
| Placebo | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period: Glucose, Potassium, Sodium and Urea/BUN. | Urea/BUN Final Value, n=44, 47 | 0.3 MMOL/L | Standard Deviation 1.5 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period: Glucose, Potassium, Sodium and Urea/BUN. | Urea/BUN Final Value, n=44, 47 | -0.1 MMOL/L | Standard Deviation 1.15 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period: Glucose, Potassium, Sodium and Urea/BUN. | Glucose OL Week 24, n=44, 47 | 0.2 MMOL/L | Standard Deviation 1.13 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period: Glucose, Potassium, Sodium and Urea/BUN. | Sodium OL Week 24, n=44, 47 | -0.6 MMOL/L | Standard Deviation 1.79 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period: Glucose, Potassium, Sodium and Urea/BUN. | Glucose Final Value, n=44, 47 | 0.2 MMOL/L | Standard Deviation 1.13 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period: Glucose, Potassium, Sodium and Urea/BUN. | Urea/BUN OL Week 24, n=44, 47 | -0.1 MMOL/L | Standard Deviation 1.15 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period: Glucose, Potassium, Sodium and Urea/BUN. | Potassium OL Week 24, n=43, 47 | -0.0 MMOL/L | Standard Deviation 0.3 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period: Glucose, Potassium, Sodium and Urea/BUN. | Sodium Final Value, n=44, 47 | -0.6 MMOL/L | Standard Deviation 1.79 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period: Glucose, Potassium, Sodium and Urea/BUN. | Potassium Final Value, n=44, 47 | -0.0 MMOL/L | Standard Deviation 0.3 |
Secondary
Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Hematocrit
Hematology parameter included: hematocrit at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline and up to Week 24
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Hematocrit | DB Week 24, n=55, 51 | -0.0 Proportion of RBCs | Standard Deviation 0.02 |
| Placebo | Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Hematocrit | Final Value, n=56, 52 | -0.0 Proportion of RBCs | Standard Deviation 0.02 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Hematocrit | DB Week 24, n=55, 51 | 0.0 Proportion of RBCs | Standard Deviation 0.02 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Hematocrit | Final Value, n=56, 52 | 0.0 Proportion of RBCs | Standard Deviation 0.02 |
Secondary
Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Hemoglobin
Hematology parameter included: hemoglobin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline and up to Week 24
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Hemoglobin | DB Week 24, n=55, 51 | -2.0 G/L | Standard Deviation 6.56 |
| Placebo | Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Hemoglobin | Final Value, n=56, 52 | -2.0 G/L | Standard Deviation 6.46 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Hemoglobin | DB Week 24, n=55, 51 | -0.8 G/L | Standard Deviation 5.33 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Hemoglobin | Final Value, n=56, 52 | -0.8 G/L | Standard Deviation 5.68 |
Secondary
Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Red Blood Cell (RBC) Count
Hematology parameter included: RBC at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline and up to Week 24
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Red Blood Cell (RBC) Count | DB Week 24, n=55, 51 | -0.0 T/L | Standard Deviation 0.25 |
| Placebo | Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Red Blood Cell (RBC) Count | Final Value, n=56, 52 | -0.0 T/L | Standard Deviation 0.25 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Red Blood Cell (RBC) Count | DB Week 24, n=55, 51 | 0.0 T/L | Standard Deviation 0.2 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Red Blood Cell (RBC) Count | Final Value, n=56, 52 | 0.0 T/L | Standard Deviation 0.21 |
Secondary
Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Hematocrit
Hematology parameter included: hematocrit at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline and up to Week 24
Population: Open-Label Period Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Hematocrit | OL Week 24, n=43, 47 | 0.0 Proportion of RBCs | Standard Deviation 0.02 |
| Placebo | Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Hematocrit | Final Value, n=43, 47 | 0.0 Proportion of RBCs | Standard Deviation 0.02 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Hematocrit | OL Week 24, n=43, 47 | 0.0 Proportion of RBCs | Standard Deviation 0.02 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Hematocrit | Final Value, n=43, 47 | 0.0 Proportion of RBCs | Standard Deviation 0.02 |
Secondary
Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Hemoglobin
Hematology parameters included: hemoglobin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline and up to Week 24
Population: Open-Label Period Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Hemoglobin | OL Week 24, n=43, 47 | -1.5 G/L | Standard Deviation 7.65 |
| Placebo | Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Hemoglobin | Final Value, n=43, 47 | -1.5 G/L | Standard Deviation 7.65 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Hemoglobin | OL Week 24, n=43, 47 | -1.4 G/L | Standard Deviation 5.3 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Hemoglobin | Final Value, n=43, 47 | -1.4 G/L | Standard Deviation 5.3 |
Secondary
Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Red Blood Cell (RBC) Count
Hematology parameter included: RBC at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline and up to Week 24
Population: Open-Label Period Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Red Blood Cell (RBC) Count | OL Week 24, n=43, 47 | -0.1 T/L | Standard Deviation 0.27 |
| Placebo | Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Red Blood Cell (RBC) Count | Final Value, n=43, 47 | -0.1 T/L | Standard Deviation 0.27 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Red Blood Cell (RBC) Count | OL Week 24, n=43, 47 | -0.1 T/L | Standard Deviation 0.2 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Red Blood Cell (RBC) Count | Final Value, n=43, 47 | -0.1 T/L | Standard Deviation 0.2 |
Secondary
Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period
Hematology parameters included: platelet count, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes, segmented neutrophils and total neutrophils at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline and up to Week 24
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Total Neutrophils DB Week 24, n=50, 46 | 0.1 Giga per Liter (GI/L) | Standard Deviation 1.27 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Eosinophils DB Week 24, n=50, 46 | -0.0 Giga per Liter (GI/L) | Standard Deviation 0.15 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | WBC DB Week 24, n=55, 51 | 0.1 Giga per Liter (GI/L) | Standard Deviation 1.39 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Eosinophils Final Value, n=51, 47 | -0.0 Giga per Liter (GI/L) | Standard Deviation 0.15 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Platelet Count DB Week 24, n=54, 47 | 2.2 Giga per Liter (GI/L) | Standard Deviation 37.79 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Lymphocytes DB Week 24, n=50, 46 | 0.0 Giga per Liter (GI/L) | Standard Deviation 0.76 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | WBC Final Value, n=56, 52 | 0.1 Giga per Liter (GI/L) | Standard Deviation 1.35 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Lymphocytes Final Value, n=51, 47 | 0.1 Giga per Liter (GI/L) | Standard Deviation 0.75 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Total Neutrophils Final Value, n=51, 47 | 0.1 Giga per Liter (GI/L) | Standard Deviation 1.26 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Monocytes DB Week 24, n=50, 46 | 0.0 Giga per Liter (GI/L) | Standard Deviation 0.16 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Basophils DB Week 24, n=50, 46 | -0.0 Giga per Liter (GI/L) | Standard Deviation 0.03 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Monocytes Final Value, n=51, 47 | 0.0 Giga per Liter (GI/L) | Standard Deviation 0.16 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Platelet Count Final Value, n=55, 48 | 2.3 Giga per Liter (GI/L) | Standard Deviation 37.45 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Segmented Neutrophils DB Week 24, n=50, 46 | 0.1 Giga per Liter (GI/L) | Standard Deviation 1.27 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Basophils Final Value, n=51, 47 | -0.0 Giga per Liter (GI/L) | Standard Deviation 0.03 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Segmented Neutrophils Final Value, n=51, 47 | 0.1 Giga per Liter (GI/L) | Standard Deviation 1.26 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Basophils Final Value, n=51, 47 | -0.0 Giga per Liter (GI/L) | Standard Deviation 0.03 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Total Neutrophils DB Week 24, n=50, 46 | 0.2 Giga per Liter (GI/L) | Standard Deviation 1.31 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Total Neutrophils Final Value, n=51, 47 | 0.2 Giga per Liter (GI/L) | Standard Deviation 1.14 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Platelet Count DB Week 24, n=54, 47 | 9.6 Giga per Liter (GI/L) | Standard Deviation 24.01 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Platelet Count Final Value, n=55, 48 | 9.0 Giga per Liter (GI/L) | Standard Deviation 23.93 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | WBC DB Week 24, n=55, 51 | 0.1 Giga per Liter (GI/L) | Standard Deviation 1.32 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | WBC Final Value, n=56, 52 | 0.1 Giga per Liter (GI/L) | Standard Deviation 1.16 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Basophils DB Week 24, n=50, 46 | -0.0 Giga per Liter (GI/L) | Standard Deviation 0.03 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Segmented Neutrophils Final Value, n=51, 47 | 0.2 Giga per Liter (GI/L) | Standard Deviation 1.14 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Eosinophils DB Week 24, n=50, 46 | -0.0 Giga per Liter (GI/L) | Standard Deviation 0.11 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Eosinophils Final Value, n=51, 47 | -0.0 Giga per Liter (GI/L) | Standard Deviation 0.13 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Lymphocytes DB Week 24, n=50, 46 | -0.1 Giga per Liter (GI/L) | Standard Deviation 0.59 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Lymphocytes Final Value, n=51, 47 | -0.0 Giga per Liter (GI/L) | Standard Deviation 0.59 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Monocytes DB Week 24, n=50, 46 | -0.0 Giga per Liter (GI/L) | Standard Deviation 0.13 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Monocytes Final Value, n=51, 47 | -0.0 Giga per Liter (GI/L) | Standard Deviation 0.13 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period | Segmented Neutrophils DB Week 24, n=50, 46 | 0.2 Giga per Liter (GI/L) | Standard Deviation 1.31 |
Secondary
Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period
Hematology parameters included: platelet count, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes, segmented neutrophils, and total neutrophils at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline and up to Week 24
Population: Open-Label Period Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Platelet Count OL Week 24, n=42, 45 | 2.1 Giga per Liter (GI/L) | Standard Deviation 30.41 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Platelet Count Final Value, n=42, 45 | 2.1 Giga per Liter (GI/L) | Standard Deviation 30.41 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | WBC OL Week 24, n=42, 47 | 0.2 Giga per Liter (GI/L) | Standard Deviation 1.23 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | WBC Final Value, n=42, 47 | 0.1 Giga per Liter (GI/L) | Standard Deviation 1.25 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Basophils OL Week 24, n=39, 44 | -0.0 Giga per Liter (GI/L) | Standard Deviation 0.02 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Basophils Final Value, n=40, 44 | -0.0 Giga per Liter (GI/L) | Standard Deviation 0.02 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Eosinophils OL Week 24, n=39, 44 | -0.0 Giga per Liter (GI/L) | Standard Deviation 0.17 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Eosinophils Final Value, n=40, 44 | -0.0 Giga per Liter (GI/L) | Standard Deviation 0.17 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Lymphocytes OL Week 24, n=39, 44 | -0.0 Giga per Liter (GI/L) | Standard Deviation 0.47 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Lymphocytes Final Value, n=40, 44 | -0.0 Giga per Liter (GI/L) | Standard Deviation 0.46 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Monocytes OL Week 24, n=39, 44 | -0.0 Giga per Liter (GI/L) | Standard Deviation 0.12 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Monocytes Final Value, n=40, 44 | -0.0 Giga per Liter (GI/L) | Standard Deviation 0.13 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Segmented Neutrophils OL Week 24, n=39, 44 | 0.2 Giga per Liter (GI/L) | Standard Deviation 1.19 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Segmented Neutrophils Final Value, n=40, 44 | 0.2 Giga per Liter (GI/L) | Standard Deviation 1.2 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Total Neutrophils OL Week 24, n=39, 44 | 0.2 Giga per Liter (GI/L) | Standard Deviation 1.19 |
| Placebo | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Total Neutrophils Final Value, n=40, 44 | 0.2 Giga per Liter (GI/L) | Standard Deviation 1.2 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Total Neutrophils Final Value, n=40, 44 | 0.0 Giga per Liter (GI/L) | Standard Deviation 1.72 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Platelet Count OL Week 24, n=42, 45 | -2.5 Giga per Liter (GI/L) | Standard Deviation 19.83 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Lymphocytes OL Week 24, n=39, 44 | 0.1 Giga per Liter (GI/L) | Standard Deviation 0.5 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Platelet Count Final Value, n=42, 45 | -3.4 Giga per Liter (GI/L) | Standard Deviation 20.33 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Segmented Neutrophils OL Week 24, n=39, 44 | 0.0 Giga per Liter (GI/L) | Standard Deviation 1.72 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | WBC OL Week 24, n=42, 47 | 0.2 Giga per Liter (GI/L) | Standard Deviation 1.71 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Lymphocytes Final Value, n=40, 44 | 0.1 Giga per Liter (GI/L) | Standard Deviation 0.5 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | WBC Final Value, n=42, 47 | 0.1 Giga per Liter (GI/L) | Standard Deviation 1.68 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Total Neutrophils OL Week 24, n=39, 44 | 0.0 Giga per Liter (GI/L) | Standard Deviation 1.72 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Basophils OL Week 24, n=39, 44 | 0.0 Giga per Liter (GI/L) | Standard Deviation 0.02 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Monocytes OL Week 24, n=39, 44 | -0.0 Giga per Liter (GI/L) | Standard Deviation 0.12 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Basophils Final Value, n=40, 44 | 0.0 Giga per Liter (GI/L) | Standard Deviation 0.02 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Segmented Neutrophils Final Value, n=40, 44 | 0.0 Giga per Liter (GI/L) | Standard Deviation 1.72 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Eosinophils OL Week 24, n=39, 44 | 0.0 Giga per Liter (GI/L) | Standard Deviation 0.14 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Monocytes Final Value, n=40, 44 | -0.0 Giga per Liter (GI/L) | Standard Deviation 0.12 |
| Dutasteride 0.5 mg | Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period | Eosinophils Final Value, n=40, 44 | 0.0 Giga per Liter (GI/L) | Standard Deviation 0.14 |
Secondary
Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period
The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline, Week 4, Week 12 and Week 24
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Intercourse satisfaction DB Week 12, n=59, 53 | -0.1 Scores on a Scale | Standard Error 0.23 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Orgasmic function DB Week 24, n=57, 52 | -0.0 Scores on a Scale | Standard Error 0.15 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Erectile Function DB Week 12, n= 59, 53 | -0.5 Scores on a Scale | Standard Error 0.35 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Sexual desire DB Week 4, n=56, 54 | -0.4 Scores on a Scale | Standard Error 0.14 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Intercourse satisfaction DB Week 24, n=57, 52 | -0.3 Scores on a Scale | Standard Error 0.23 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Sexual desire DB Week 12, n=59, 53 | -0.2 Scores on a Scale | Standard Error 0.15 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Intercourse satisfaction DB Week 4, n=56, 54 | -0.3 Scores on a Scale | Standard Error 0.16 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Sexual desire DB Week 24, n=57, 52 | -0.2 Scores on a Scale | Standard Error 0.18 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Orgasmic function DB Week 4, n=56, 54 | -0.0 Scores on a Scale | Standard Error 0.11 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Overall sexual satisfaction DB Week 4, n=56, 54 | -0.1 Scores on a Scale | Standard Error 0.12 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Erectile Function DB Week 24, n=57, 52 | -0.5 Scores on a Scale | Standard Error 0.42 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Overall sexual satisfaction DB Week 12, n=59, 53 | -0.1 Scores on a Scale | Standard Error 0.13 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Orgasmic function DB Week 12, n=59, 53 | 0.0 Scores on a Scale | Standard Error 0.1 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Overall sexual satisfaction DB Week 24, n=57, 51 | -0.1 Scores on a Scale | Standard Error 0.15 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Erectile Function DB Week 4, n=56, 54 | -0.5 Scores on a Scale | Standard Error 0.23 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Overall sexual satisfaction DB Week 24, n=57, 51 | -0.2 Scores on a Scale | Standard Error 0.16 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Erectile Function DB Week 4, n=56, 54 | -0.3 Scores on a Scale | Standard Error 0.24 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Erectile Function DB Week 12, n= 59, 53 | -1.3 Scores on a Scale | Standard Error 0.37 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Erectile Function DB Week 24, n=57, 52 | -1.2 Scores on a Scale | Standard Error 0.44 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Intercourse satisfaction DB Week 4, n=56, 54 | 0.0 Scores on a Scale | Standard Error 0.16 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Intercourse satisfaction DB Week 12, n=59, 53 | -0.2 Scores on a Scale | Standard Error 0.24 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Intercourse satisfaction DB Week 24, n=57, 52 | -0.4 Scores on a Scale | Standard Error 0.24 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Orgasmic function DB Week 4, n=56, 54 | 0.1 Scores on a Scale | Standard Error 0.11 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Orgasmic function DB Week 12, n=59, 53 | -0.1 Scores on a Scale | Standard Error 0.11 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Orgasmic function DB Week 24, n=57, 52 | -0.1 Scores on a Scale | Standard Error 0.16 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Sexual desire DB Week 4, n=56, 54 | -0.1 Scores on a Scale | Standard Error 0.15 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Sexual desire DB Week 12, n=59, 53 | -0.4 Scores on a Scale | Standard Error 0.16 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Sexual desire DB Week 24, n=57, 52 | -0.2 Scores on a Scale | Standard Error 0.19 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Overall sexual satisfaction DB Week 4, n=56, 54 | 0.1 Scores on a Scale | Standard Error 0.12 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period | Overall sexual satisfaction DB Week 12, n=59, 53 | -0.2 Scores on a Scale | Standard Error 0.14 |
p-value: 0.4695% CI: [-0.4, 0.9]t-test from general linear model
p-value: 0.1495% CI: [-1.8, 0.3]t-test from general linear model
p-value: 0.2795% CI: [-1.9, 0.5]t-test from general linear model
p-value: 0.1395% CI: [-0.1, 0.8]t-test from general linear model
p-value: 0.7395% CI: [-0.8, 0.5]t-test from general linear model
p-value: 0.6495% CI: [-0.8, 0.5]t-test from general linear model
p-value: 0.2395% CI: [-0.1, 0.5]t-test from general linear model
p-value: 0.3395% CI: [-0.5, 0.2]t-test from general linear model
p-value: 0.6495% CI: [-0.6, 0.3]t-test from general linear model
p-value: 0.1995% CI: [-0.1, 0.7]t-test from general linear model
p-value: 0.2895% CI: [-0.7, 0.2]t-test from general linear model
p-value: 195% CI: [-0.5, 0.5]t-test from general linear model
p-value: 0.2895% CI: [-0.2, 0.5]t-test from general linear model
p-value: 0.6495% CI: [-0.5, 0.3]t-test from general linear model
p-value: 0.6995% CI: [-0.5, 0.3]t-test from general linear model
Secondary
Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period
The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The Baseline assessment was defined as the latest assessment on or before the OL treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline, Week 4, Week 12 and Week 24
Population: Open-label Period Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Intercourse satisfaction OL Week 12, n= 46, 48 | -0.2 Scores on a Scale | Standard Deviation 1.57 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Orgasmic function OL Week 24, n=44, 47 | 0.1 Scores on a Scale | Standard Deviation 0.8 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Erectile Function OL Week 12, n= 46, 48 | -0.1 Scores on a Scale | Standard Deviation 1.86 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Sexual desire OL Week 4, n=47, 48 | 0.1 Scores on a Scale | Standard Deviation 1.5 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Intercourse satisfaction OL Week 24, n=44, 47 | -0.1 Scores on a Scale | Standard Deviation 1.93 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Sexual desire OL Week 12, n= 46, 48 | -0.2 Scores on a Scale | Standard Deviation 1.6 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Intercourse satisfaction OL Week 4, n=47, 48 | 0.1 Scores on a Scale | Standard Deviation 1.45 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Sexual desire OL Week 24, n=44, 47 | -0.0 Scores on a Scale | Standard Deviation 1.72 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Orgasmic function OL Week 4, n=47, 48 | 0.1 Scores on a Scale | Standard Deviation 0.88 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Overall sexual satisfaction OL Week 4, n=47, 48 | 0.0 Scores on a Scale | Standard Deviation 1.13 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Erectile Function OL Week 24, n=44, 47 | 0.0 Scores on a Scale | Standard Deviation 1.62 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Overall sexual satisfaction OL Week 12, n= 46, 48 | -0.2 Scores on a Scale | Standard Deviation 0.99 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Orgasmic function OL Week 12, n= 46, 48 | 0.0 Scores on a Scale | Standard Deviation 0.8 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Overall sexual satisfaction OL Week 24, n=44, 47 | -0.2 Scores on a Scale | Standard Deviation 1.1 |
| Placebo | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Erectile Function OL Week 4, n=47, 48 | 0.0 Scores on a Scale | Standard Deviation 2.3 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Overall sexual satisfaction OL Week 24, n=44, 47 | -0.1 Scores on a Scale | Standard Deviation 1.45 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Erectile Function OL Week 4, n=47, 48 | -0.1 Scores on a Scale | Standard Deviation 1.76 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Erectile Function OL Week 12, n= 46, 48 | -0.3 Scores on a Scale | Standard Deviation 2.99 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Erectile Function OL Week 24, n=44, 47 | -1.4 Scores on a Scale | Standard Deviation 5.22 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Intercourse satisfaction OL Week 4, n=47, 48 | 0.0 Scores on a Scale | Standard Deviation 1.03 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Intercourse satisfaction OL Week 12, n= 46, 48 | -0.1 Scores on a Scale | Standard Deviation 1.93 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Intercourse satisfaction OL Week 24, n=44, 47 | -0.5 Scores on a Scale | Standard Deviation 2.6 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Orgasmic function OL Week 4, n=47, 48 | 0.1 Scores on a Scale | Standard Deviation 0.65 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Orgasmic function OL Week 12, n= 46, 48 | -0.1 Scores on a Scale | Standard Deviation 0.56 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Orgasmic function OL Week 24, n=44, 47 | -0.4 Scores on a Scale | Standard Deviation 2.12 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Sexual desire OL Week 4, n=47, 48 | 0.0 Scores on a Scale | Standard Deviation 1.01 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Sexual desire OL Week 12, n= 46, 48 | -0.1 Scores on a Scale | Standard Deviation 1.07 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Sexual desire OL Week 24, n=44, 47 | -0.1 Scores on a Scale | Standard Deviation 1.04 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Overall sexual satisfaction OL Week 4, n=47, 48 | 0.1 Scores on a Scale | Standard Deviation 0.73 |
| Dutasteride 0.5 mg | Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period | Overall sexual satisfaction OL Week 12, n= 46, 48 | 0.2 Scores on a Scale | Standard Deviation 0.71 |
Secondary
Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) in the Double-blind Treatment Period
The DLQI was a 10-item questionnaire designed to evaluate the effect of skin conditions (alopecia) on the participants quality of life. Each item was scored on a 4-point scale ranging from 0 to 3 with a maximum score of 30. Higher scores represent greater impairment in quality of life. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline, Week 12 and Week 24
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) in the Double-blind Treatment Period | DB Week 12, n= 58, 53 | 0.2 Scores on a Scale | Standard Error 0.35 |
| Placebo | Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) in the Double-blind Treatment Period | DB Week 24, n=57, 52 | 0.7 Scores on a Scale | Standard Error 0.52 |
| Dutasteride 0.5 mg | Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) in the Double-blind Treatment Period | DB Week 12, n= 58, 53 | -0.4 Scores on a Scale | Standard Error 0.37 |
| Dutasteride 0.5 mg | Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) in the Double-blind Treatment Period | DB Week 24, n=57, 52 | 0.2 Scores on a Scale | Standard Error 0.55 |
p-value: 0.2295% CI: [-1.7, 0.4]t-test from general linear model
p-value: 0.595% CI: [-2, 1]t-test from general linear model
Secondary
Change From Baseline in the Total Score of the DLQI in the Open-label Treatment Period
The DLQI was a 10-item questionnaire designed to evaluate the effect of skin conditions (alopecia) on the participants quality of life. Each item was scored on a 4-point scale ranging from 0 to 3 with a maximum score of 30. Higher scores represent greater impairment in quality of life. The Baseline assessment was defined as the latest assessment on or before the OL treatment start. Change from Baseline is post-Baseline value minus Baseline value.
Time frame: Baseline and Upto Week 24
Population: Open-label Period Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Total Score of the DLQI in the Open-label Treatment Period | -1.0 Scores on a Scale | Standard Deviation 3.92 |
| Dutasteride 0.5 mg | Change From Baseline in the Total Score of the DLQI in the Open-label Treatment Period | -0.8 Scores on a Scale | Standard Deviation 3.77 |
Secondary
Change From Baseline in Total Score of the IIEF in the Double-blind Treatment Period
The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The change from Baseline values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline, Week 4, Week 12 and Week 24
Population: Safety Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Total Score of the IIEF in the Double-blind Treatment Period | DB Week 4, n=56, 54 | -1.4 Scores on a Scale | Standard Error 0.56 |
| Placebo | Change From Baseline in Total Score of the IIEF in the Double-blind Treatment Period | DB Week 12, n= 59, 53 | -0.9 Scores on a Scale | Standard Error 0.75 |
| Placebo | Change From Baseline in Total Score of the IIEF in the Double-blind Treatment Period | DB Week 24, n=57, 51 | -1.2 Scores on a Scale | Standard Error 0.71 |
| Dutasteride 0.5 mg | Change From Baseline in Total Score of the IIEF in the Double-blind Treatment Period | DB Week 4, n=56, 54 | -0.0 Scores on a Scale | Standard Error 0.57 |
| Dutasteride 0.5 mg | Change From Baseline in Total Score of the IIEF in the Double-blind Treatment Period | DB Week 12, n= 59, 53 | -2.2 Scores on a Scale | Standard Error 0.79 |
| Dutasteride 0.5 mg | Change From Baseline in Total Score of the IIEF in the Double-blind Treatment Period | DB Week 24, n=57, 51 | -1.2 Scores on a Scale | Standard Error 0.75 |
p-value: 0.08295% CI: [-0.2, 3]t-test from general linear model
p-value: 0.2595% CI: [-3.4, 0.9]t-test from general linear model
p-value: 0.9995% CI: [-2, 2.1]t-test from general linear model
Secondary
Change From Baseline in Total Score of the IIEF in the Open-label Treatment Period
The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The change from Baseline values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: Baseline, Week 4, Week 12 and Week 24
Population: Open-Label Period Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Total Score of the IIEF in the Open-label Treatment Period | OL Week 4, n=47, 48 | 0.4 Scores on a Scale | Standard Deviation 5.55 |
| Placebo | Change From Baseline in Total Score of the IIEF in the Open-label Treatment Period | OL Week 12, n=46, 48 | -0.6 Scores on a Scale | Standard Deviation 5.28 |
| Placebo | Change From Baseline in Total Score of the IIEF in the Open-label Treatment Period | OL Week 24, n=44, 47 | -0.1 Scores on a Scale | Standard Deviation 5.73 |
| Dutasteride 0.5 mg | Change From Baseline in Total Score of the IIEF in the Open-label Treatment Period | OL Week 4, n=47, 48 | 0.2 Scores on a Scale | Standard Deviation 3.04 |
| Dutasteride 0.5 mg | Change From Baseline in Total Score of the IIEF in the Open-label Treatment Period | OL Week 12, n=46, 48 | -0.3 Scores on a Scale | Standard Deviation 5.34 |
| Dutasteride 0.5 mg | Change From Baseline in Total Score of the IIEF in the Open-label Treatment Period | OL Week 24, n=44, 47 | -2.6 Scores on a Scale | Standard Deviation 11.05 |
Secondary
Duration and Persistence of AEs Related to Sexual Function in the Double-blind and Open-label Combined Periods
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. Duration is the total number of non-overlapping days for all events per subject. A duration is censored if there is at least one event with unknown start date or end date, in which case the censored duration is the minimum number of days that a subject has experienced any of these events. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA=not applicable.
Time frame: 48 weeks
Population: Dutasteride DB/OL Combined population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Duration and Persistence of AEs Related to Sexual Function in the Double-blind and Open-label Combined Periods | Altered (decreased) libido n=1 | 135.0 Days | — |
| Placebo | Duration and Persistence of AEs Related to Sexual Function in the Double-blind and Open-label Combined Periods | Impotence, n=8 | 90.8 Days | Standard Deviation 84.28 |
| Placebo | Duration and Persistence of AEs Related to Sexual Function in the Double-blind and Open-label Combined Periods | Ejaculation disorder, n=1 | 63.0 Days | — |
Secondary
Duration and Persistence of AEs Related to Sexual Function in the Double-blind Treatment Period
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. Duration is the total number of non-overlapping days for all events per subject. A duration is censored if there is at least one event with unknown start date or end date, in which case the censored duration is the minimum number of days that a subject has experienced any of these events. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA=not applicable.
Time frame: 24 weeks
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Duration and Persistence of AEs Related to Sexual Function in the Double-blind Treatment Period | Altered (decreased) libido n=2,1 | 88.5 Days | Standard Deviation 103.94 |
| Placebo | Duration and Persistence of AEs Related to Sexual Function in the Double-blind Treatment Period | Impotence, n=3, 7 | 68.3 Days | Standard Deviation 73.35 |
| Placebo | Duration and Persistence of AEs Related to Sexual Function in the Double-blind Treatment Period | Ejaculation disorder, n=0, 1 | NA Days | — |
| Dutasteride 0.5 mg | Duration and Persistence of AEs Related to Sexual Function in the Double-blind Treatment Period | Altered (decreased) libido n=2,1 | 44.0 Days | — |
| Dutasteride 0.5 mg | Duration and Persistence of AEs Related to Sexual Function in the Double-blind Treatment Period | Impotence, n=3, 7 | 78.6 Days | Standard Deviation 83.09 |
| Dutasteride 0.5 mg | Duration and Persistence of AEs Related to Sexual Function in the Double-blind Treatment Period | Ejaculation disorder, n=0, 1 | 63.0 Days | — |
Secondary
Duration and Persistence of AEs Related to Sexual Function in the Open-label Treatment Period
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. Duration is the total number of non-overlapping days for all events per subject. A duration is censored if there is at least one event with unknown start date or end date, in which case the censored duration is the minimum number of days that a subject has experienced any of these events. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA=not applicable.
Time frame: 24 weeks
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Duration and Persistence of AEs Related to Sexual Function in the Open-label Treatment Period | Altered (decreased) libido n=2,1 | 77.5 Days | Standard Deviation 71.42 |
| Placebo | Duration and Persistence of AEs Related to Sexual Function in the Open-label Treatment Period | Impotence, n=1, 1 | 181.0 Days | — |
| Placebo | Duration and Persistence of AEs Related to Sexual Function in the Open-label Treatment Period | Ejaculation disorder, n=0, 0 | NA Days | — |
| Dutasteride 0.5 mg | Duration and Persistence of AEs Related to Sexual Function in the Open-label Treatment Period | Altered (decreased) libido n=2,1 | 135.0 Days | — |
| Dutasteride 0.5 mg | Duration and Persistence of AEs Related to Sexual Function in the Open-label Treatment Period | Impotence, n=1, 1 | 176.0 Days | — |
| Dutasteride 0.5 mg | Duration and Persistence of AEs Related to Sexual Function in the Open-label Treatment Period | Ejaculation disorder, n=0, 0 | NA Days | — |
Secondary
Incidence of Premature Discontinuations in the Double-blind Treatment Period
Participants were referred as premature discontinuations if they do not complete the double-blind period. The reasons for premature withdrawal were protocol deviation, lost to follow-up and withdrawal of consent by participants.
Time frame: Week 24
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Incidence of Premature Discontinuations in the Double-blind Treatment Period | 2 Participants |
| Dutasteride 0.5 mg | Incidence of Premature Discontinuations in the Double-blind Treatment Period | 6 Participants |
Secondary
Incidence of Premature Discontinuations in the Open-label Treatment Period
Participants were referred as premature discontinuations if they do not complete the open-label treatment period. The reasons for premature withdrawal were protocol deviation, lost to follow-up and withdrawal of consent by participants.
Time frame: Week 48
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Incidence of Premature Discontinuations in the Open-label Treatment Period | 5 Participants |
| Dutasteride 0.5 mg | Incidence of Premature Discontinuations in the Open-label Treatment Period | 1 Participants |
Secondary
Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Double-blind and Open-label Combined Periods
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.
Time frame: 48 weeks
Population: Dutasteride DB/OL Combined population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Double-blind and Open-label Combined Periods | 0 Participants |
Secondary
Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Double-blind Treatment Period
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.
Time frame: 24 weeks
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Double-blind Treatment Period | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Double-blind Treatment Period | 0 Participants |
Secondary
Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Open-label Treatment Period
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.
Time frame: 24 weeks
Population: Open-Label Period Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Open-label Treatment Period | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Open-label Treatment Period | 0 Participants |
Secondary
Number of Participants With a Change in Sexual Function Defined as a Negative Change From Baseline in the IIEF Erectile Function Domain (IIEF-EF) Score of >=4 Units in the Open-label Treatment Period
The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. The erectile function domain of the IIEF (IIEF-EF) includes Questions 1 through 5 and Question 15 (maximum score of 30). A clinically meaningful gradient of severity of erectile dysfunction (ED) has been developed, indicating that a score of greater than 25 represents an individual without ED while men scoring \<=25 may be classified as having ED. The values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value.
Time frame: Baseline, Week 4, Week 12 and Week 24
Population: Open-Label Period Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With a Change in Sexual Function Defined as a Negative Change From Baseline in the IIEF Erectile Function Domain (IIEF-EF) Score of >=4 Units in the Open-label Treatment Period | OL Week 4 | 2 Participants |
| Placebo | Number of Participants With a Change in Sexual Function Defined as a Negative Change From Baseline in the IIEF Erectile Function Domain (IIEF-EF) Score of >=4 Units in the Open-label Treatment Period | OL Week 12 | 2 Participants |
| Placebo | Number of Participants With a Change in Sexual Function Defined as a Negative Change From Baseline in the IIEF Erectile Function Domain (IIEF-EF) Score of >=4 Units in the Open-label Treatment Period | OL Week 24 | 1 Participants |
| Dutasteride 0.5 mg | Number of Participants With a Change in Sexual Function Defined as a Negative Change From Baseline in the IIEF Erectile Function Domain (IIEF-EF) Score of >=4 Units in the Open-label Treatment Period | OL Week 4 | 2 Participants |
| Dutasteride 0.5 mg | Number of Participants With a Change in Sexual Function Defined as a Negative Change From Baseline in the IIEF Erectile Function Domain (IIEF-EF) Score of >=4 Units in the Open-label Treatment Period | OL Week 12 | 3 Participants |
| Dutasteride 0.5 mg | Number of Participants With a Change in Sexual Function Defined as a Negative Change From Baseline in the IIEF Erectile Function Domain (IIEF-EF) Score of >=4 Units in the Open-label Treatment Period | OL Week 24 | 5 Participants |
Secondary
Number of Participants With a Change in Sexual Function Defined as a Negative Change From Baseline in the International Index of Erectile Function (IIEF) Erectile Function Domain (IIEF-EF) Score of >=4 Units in the Double-blind Treatment Period
The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. The erectile function domain of the IIEF (IIEF-EF) includes Questions 1 through 5 and Question 15 (maximum score of 30). A clinically meaningful gradient of severity of erectile dysfunction (ED) has been developed, indicating that a score of greater than 25 represents an individual without ED while men scoring \<=25 may be classified as having ED. The values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value.
Time frame: Baseline, Week 4, Week 12 and Week 24
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With a Change in Sexual Function Defined as a Negative Change From Baseline in the International Index of Erectile Function (IIEF) Erectile Function Domain (IIEF-EF) Score of >=4 Units in the Double-blind Treatment Period | DB Week 4 | 3 Participants |
| Placebo | Number of Participants With a Change in Sexual Function Defined as a Negative Change From Baseline in the International Index of Erectile Function (IIEF) Erectile Function Domain (IIEF-EF) Score of >=4 Units in the Double-blind Treatment Period | DB Week 12 | 4 Participants |
| Placebo | Number of Participants With a Change in Sexual Function Defined as a Negative Change From Baseline in the International Index of Erectile Function (IIEF) Erectile Function Domain (IIEF-EF) Score of >=4 Units in the Double-blind Treatment Period | DB Week 24 | 3 Participants |
| Dutasteride 0.5 mg | Number of Participants With a Change in Sexual Function Defined as a Negative Change From Baseline in the International Index of Erectile Function (IIEF) Erectile Function Domain (IIEF-EF) Score of >=4 Units in the Double-blind Treatment Period | DB Week 4 | 1 Participants |
| Dutasteride 0.5 mg | Number of Participants With a Change in Sexual Function Defined as a Negative Change From Baseline in the International Index of Erectile Function (IIEF) Erectile Function Domain (IIEF-EF) Score of >=4 Units in the Double-blind Treatment Period | DB Week 12 | 7 Participants |
| Dutasteride 0.5 mg | Number of Participants With a Change in Sexual Function Defined as a Negative Change From Baseline in the International Index of Erectile Function (IIEF) Erectile Function Domain (IIEF-EF) Score of >=4 Units in the Double-blind Treatment Period | DB Week 24 | 6 Participants |
p-value: 0.6295% CI: [-10.4, 3.4]Fisher's Exact Test
p-value: 0.3495% CI: [-4.7, 17.6]Fisher's Exact Test
p-value: 0.3195% CI: [-4.2, 16.7]Fisher's Exact Test
Secondary
Number of Participants With AEs of Special Interest in the Double-blind and Open-label Combined Periods
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs of special interest included those of sexual function: breast disorders (breast enlargement and breast tenderness), prostate cancer, cardiovascular events, and possible suicidality-related AEs (PSRAEs). Infrequent AEs of special interest included breast cancer, allergic reactions, depressed mood, hair changes, interference with formation of external genitalia in a male fetus, potential for decreased male fertility, and testicular pain and swelling. Special interest AEs are groups of MedDRA terms which have been defined in the analysis plan.
Time frame: 48 weeks
Population: Dutasteride DB/OL Combined population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With AEs of Special Interest in the Double-blind and Open-label Combined Periods | Altered (decreased libido) | 1 Participants |
| Placebo | Number of Participants With AEs of Special Interest in the Double-blind and Open-label Combined Periods | Impotence | 8 Participants |
| Placebo | Number of Participants With AEs of Special Interest in the Double-blind and Open-label Combined Periods | Ejaculation disorders | 1 Participants |
| Placebo | Number of Participants With AEs of Special Interest in the Double-blind and Open-label Combined Periods | Breast disorder | 0 Participants |
| Placebo | Number of Participants With AEs of Special Interest in the Double-blind and Open-label Combined Periods | Prostate cancer | 0 Participants |
| Placebo | Number of Participants With AEs of Special Interest in the Double-blind and Open-label Combined Periods | Cardiovascular adverse event | 0 Participants |
| Placebo | Number of Participants With AEs of Special Interest in the Double-blind and Open-label Combined Periods | Infrequent adverse events | 2 Participants |
Secondary
Number of Participants With AEs of Special Interest in the Double-blind Treatment Period
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs of special interest included those of sexual function: breast disorders (breast enlargement and breast tenderness), prostate cancer, cardiovascular events, and possible suicidality-related AEs (PSRAEs). Infrequent AEs of special interest included breast cancer, allergic reactions, depressed mood, hair changes, interference with formation of external genitalia in a male fetus, potential for decreased male fertility, and testicular pain and swelling. Special interest AEs are groups of MedDRA terms which have been defined in the analysis plan.
Time frame: 24 weeks
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With AEs of Special Interest in the Double-blind Treatment Period | Ejaculation disorders | 0 Participants |
| Placebo | Number of Participants With AEs of Special Interest in the Double-blind Treatment Period | Prostate cancer | 0 Participants |
| Placebo | Number of Participants With AEs of Special Interest in the Double-blind Treatment Period | Impotence | 3 Participants |
| Placebo | Number of Participants With AEs of Special Interest in the Double-blind Treatment Period | Cardiovascular adverse event | 0 Participants |
| Placebo | Number of Participants With AEs of Special Interest in the Double-blind Treatment Period | Breast disorder | 0 Participants |
| Placebo | Number of Participants With AEs of Special Interest in the Double-blind Treatment Period | Infrequent adverse events | 0 Participants |
| Placebo | Number of Participants With AEs of Special Interest in the Double-blind Treatment Period | Altered (decreased libido) | 2 Participants |
| Dutasteride 0.5 mg | Number of Participants With AEs of Special Interest in the Double-blind Treatment Period | Infrequent adverse events | 1 Participants |
| Dutasteride 0.5 mg | Number of Participants With AEs of Special Interest in the Double-blind Treatment Period | Altered (decreased libido) | 1 Participants |
| Dutasteride 0.5 mg | Number of Participants With AEs of Special Interest in the Double-blind Treatment Period | Impotence | 7 Participants |
| Dutasteride 0.5 mg | Number of Participants With AEs of Special Interest in the Double-blind Treatment Period | Ejaculation disorders | 1 Participants |
| Dutasteride 0.5 mg | Number of Participants With AEs of Special Interest in the Double-blind Treatment Period | Breast disorder | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants With AEs of Special Interest in the Double-blind Treatment Period | Prostate cancer | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants With AEs of Special Interest in the Double-blind Treatment Period | Cardiovascular adverse event | 0 Participants |
Secondary
Number of Participants With AEs of Special Interest in the Open-label Treatment Period
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs of special interest included those of sexual function: breast disorders (breast enlargement and breast tenderness), prostate cancer, cardiovascular events, and possible suicidality-related AEs (PSRAEs). Infrequent AEs of special interest included breast cancer, allergic reactions, depressed mood, hair changes, interference with formation of external genitalia in a male fetus, potential for decreased male fertility, and testicular pain and swelling. Special interest AEs are groups of MedDRA terms which have been defined in the analysis plan.
Time frame: 24 weeks
Population: Open-Label Period Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With AEs of Special Interest in the Open-label Treatment Period | Ejaculation disorders | 0 Participants |
| Placebo | Number of Participants With AEs of Special Interest in the Open-label Treatment Period | Prostate cancer | 0 Participants |
| Placebo | Number of Participants With AEs of Special Interest in the Open-label Treatment Period | Impotence | 1 Participants |
| Placebo | Number of Participants With AEs of Special Interest in the Open-label Treatment Period | Cardiovascular adverse event | 0 Participants |
| Placebo | Number of Participants With AEs of Special Interest in the Open-label Treatment Period | Breast disorder | 0 Participants |
| Placebo | Number of Participants With AEs of Special Interest in the Open-label Treatment Period | Infrequent adverse events | 0 Participants |
| Placebo | Number of Participants With AEs of Special Interest in the Open-label Treatment Period | Altered (decreased libido) | 2 Participants |
| Dutasteride 0.5 mg | Number of Participants With AEs of Special Interest in the Open-label Treatment Period | Infrequent adverse events | 1 Participants |
| Dutasteride 0.5 mg | Number of Participants With AEs of Special Interest in the Open-label Treatment Period | Altered (decreased libido) | 1 Participants |
| Dutasteride 0.5 mg | Number of Participants With AEs of Special Interest in the Open-label Treatment Period | Impotence | 1 Participants |
| Dutasteride 0.5 mg | Number of Participants With AEs of Special Interest in the Open-label Treatment Period | Ejaculation disorders | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants With AEs of Special Interest in the Open-label Treatment Period | Breast disorder | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants With AEs of Special Interest in the Open-label Treatment Period | Prostate cancer | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants With AEs of Special Interest in the Open-label Treatment Period | Cardiovascular adverse event | 0 Participants |
Secondary
Number of Participants With AEs, SAEs and PSRAEs in the Double-blind and Open-label Combined Periods
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.. SAE is defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment, all events of possible drug-induced liver injury with hyperbilirubinemia, breast cancer in male participants, or spontaneous abortion in female partner of male participant. The PSRAE form was used in this study to collect detailed information on the circumstances of reported AEs which, in the investigator's opinion, were possibly suicidality-related.
Time frame: 48 weeks
Population: Dutasteride DB/OL Combined population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With AEs, SAEs and PSRAEs in the Double-blind and Open-label Combined Periods | Any AE | 25 Participants |
| Placebo | Number of Participants With AEs, SAEs and PSRAEs in the Double-blind and Open-label Combined Periods | Any SAE | 1 Participants |
| Placebo | Number of Participants With AEs, SAEs and PSRAEs in the Double-blind and Open-label Combined Periods | PSRAE | 0 Participants |
Secondary
Number of Participants With AEs, SAEs and PSRAEs in the Open-label Treatment Period
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.. SAE is defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment, all events of possible drug-induced liver injury with hyperbilirubinemia, breast cancer in male participants, or spontaneous abortion in female partner of male participant. The PSRAE form was used in this study to collect detailed information on the circumstances of reported AEs which, in the investigator's opinion, were possibly suicidality-related.
Time frame: 24 weeks
Population: Open-Label Period Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With AEs, SAEs and PSRAEs in the Open-label Treatment Period | Any AE | 13 Participants |
| Placebo | Number of Participants With AEs, SAEs and PSRAEs in the Open-label Treatment Period | Any SAE | 1 Participants |
| Placebo | Number of Participants With AEs, SAEs and PSRAEs in the Open-label Treatment Period | PSRAE | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants With AEs, SAEs and PSRAEs in the Open-label Treatment Period | Any AE | 15 Participants |
| Dutasteride 0.5 mg | Number of Participants With AEs, SAEs and PSRAEs in the Open-label Treatment Period | Any SAE | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants With AEs, SAEs and PSRAEs in the Open-label Treatment Period | PSRAE | 0 Participants |
Secondary
Number of Participants With AEs, Serious AEs (SAEs) and Possible Suicidality Related Adverse Events (PSRAEs) in the Double-blind Treatment Period
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment, all events of possible drug-induced liver injury with hyperbilirubinemia, breast cancer in male participants, or spontaneous abortion in female partner of male participant. The PSRAE form was used in this study to collect detailed information on the circumstances of reported AEs which, in the investigator's opinion, were possibly suicidality-related.
Time frame: 24 weeks
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With AEs, Serious AEs (SAEs) and Possible Suicidality Related Adverse Events (PSRAEs) in the Double-blind Treatment Period | Any AE | 18 Participants |
| Placebo | Number of Participants With AEs, Serious AEs (SAEs) and Possible Suicidality Related Adverse Events (PSRAEs) in the Double-blind Treatment Period | Any SAE | 1 Participants |
| Placebo | Number of Participants With AEs, Serious AEs (SAEs) and Possible Suicidality Related Adverse Events (PSRAEs) in the Double-blind Treatment Period | PSRAE | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants With AEs, Serious AEs (SAEs) and Possible Suicidality Related Adverse Events (PSRAEs) in the Double-blind Treatment Period | Any AE | 19 Participants |
| Dutasteride 0.5 mg | Number of Participants With AEs, Serious AEs (SAEs) and Possible Suicidality Related Adverse Events (PSRAEs) in the Double-blind Treatment Period | Any SAE | 1 Participants |
| Dutasteride 0.5 mg | Number of Participants With AEs, Serious AEs (SAEs) and Possible Suicidality Related Adverse Events (PSRAEs) in the Double-blind Treatment Period | PSRAE | 0 Participants |
Secondary
Number of Participants With Frequency of Heart Rate of Clinical Concern in the Double-blind Treatment Period
The Baseline heart rate assessment was defined as the latest assessment on or before the double-blind treatment start. The clinical concern range for heart rate was defined as: (lower: \<40, upper: \>100).
Time frame: Baseline and up to Week 24
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Frequency of Heart Rate of Clinical Concern in the Double-blind Treatment Period | Baseline <40 | 0 Participants |
| Placebo | Number of Participants With Frequency of Heart Rate of Clinical Concern in the Double-blind Treatment Period | Baseline >100 | 1 Participants |
| Placebo | Number of Participants With Frequency of Heart Rate of Clinical Concern in the Double-blind Treatment Period | Post- Baseline <40 | 0 Participants |
| Placebo | Number of Participants With Frequency of Heart Rate of Clinical Concern in the Double-blind Treatment Period | Post- Baseline >100 | 1 Participants |
| Dutasteride 0.5 mg | Number of Participants With Frequency of Heart Rate of Clinical Concern in the Double-blind Treatment Period | Post- Baseline >100 | 2 Participants |
| Dutasteride 0.5 mg | Number of Participants With Frequency of Heart Rate of Clinical Concern in the Double-blind Treatment Period | Baseline <40 | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants With Frequency of Heart Rate of Clinical Concern in the Double-blind Treatment Period | Post- Baseline <40 | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants With Frequency of Heart Rate of Clinical Concern in the Double-blind Treatment Period | Baseline >100 | 1 Participants |
Secondary
Number of Participants With Frequency of Heart Rate of Clinical Concern in the Open-label Treatment Period
Baseline heart rate assessment was defined as the latest assessment on or before the open-label treatment start. The clinical concern range for heart rate was defined as: (lower: \<40, upper: \>100).
Time frame: Baseline and up to Week 24
Population: Open-Label Period Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Frequency of Heart Rate of Clinical Concern in the Open-label Treatment Period | Baseline >100 | 1 Participants |
| Placebo | Number of Participants With Frequency of Heart Rate of Clinical Concern in the Open-label Treatment Period | Baseline <40 | 0 Participants |
| Placebo | Number of Participants With Frequency of Heart Rate of Clinical Concern in the Open-label Treatment Period | Post- Baseline <40 | 0 Participants |
| Placebo | Number of Participants With Frequency of Heart Rate of Clinical Concern in the Open-label Treatment Period | Post- Baseline >100 | 3 Participants |
| Dutasteride 0.5 mg | Number of Participants With Frequency of Heart Rate of Clinical Concern in the Open-label Treatment Period | Post- Baseline >100 | 5 Participants |
| Dutasteride 0.5 mg | Number of Participants With Frequency of Heart Rate of Clinical Concern in the Open-label Treatment Period | Post- Baseline <40 | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants With Frequency of Heart Rate of Clinical Concern in the Open-label Treatment Period | Baseline <40 | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants With Frequency of Heart Rate of Clinical Concern in the Open-label Treatment Period | Baseline >100 | 1 Participants |
Secondary
Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period
The Baseline blood presssure assessment was defined as the latest assessment on or before the double-blind treatment start. The clinical concern range for vital signs was defined as: Systolic blood pressure (lower: \<80, upper: \>165) and diastolic blood pressure: (lower: \<40, upper: \>105).
Time frame: Baseline and up to Week 24
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period | Baseline SBP <80 mmHg | 0 Participants |
| Placebo | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period | Baseline SBP >165 mmHg | 0 Participants |
| Placebo | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period | Baseline DBP <40 mmHg | 0 Participants |
| Placebo | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period | Baseline DBP >105 mmHg | 0 Participants |
| Placebo | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period | Post Baseline SBP <80 mmHg | 0 Participants |
| Placebo | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period | Post Baseline SBP >165 mmHg | 0 Participants |
| Placebo | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period | Post Baseline DBP <40 mmHg | 0 Participants |
| Placebo | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period | Post Baseline DBP >105 mmHg | 1 Participants |
| Dutasteride 0.5 mg | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period | Post Baseline DBP >105 mmHg | 2 Participants |
| Dutasteride 0.5 mg | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period | Baseline SBP <80 mmHg | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period | Post Baseline SBP <80 mmHg | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period | Baseline SBP >165 mmHg | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period | Post Baseline DBP <40 mmHg | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period | Baseline DBP <40 mmHg | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period | Post Baseline SBP >165 mmHg | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period | Baseline DBP >105 mmHg | 0 Participants |
Secondary
Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period
The Baseline blood presssure assessment was defined as the latest assessment on or before the open-label treatment start. The clinical concern range for vital signs was defined as: systolic blood pressure (lower: \<80, upper: \>165) and diastolic blood pressure: (lower: \<40, upper: \>105).
Time frame: Baseline and up to Week 24
Population: Open-Label Period Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period | Baseline SBP <80 mmHg | 0 Participants |
| Placebo | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period | Baseline SBP >165 mmHg | 0 Participants |
| Placebo | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period | Baseline DBP <40 mmHg | 0 Participants |
| Placebo | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period | Baseline DBP >105 mmHg | 0 Participants |
| Placebo | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period | Post Baseline SBP <80 mmHg | 0 Participants |
| Placebo | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period | Post Baseline SBP >165 mmHg | 0 Participants |
| Placebo | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period | Post Baseline DBP <40 mmHg | 0 Participants |
| Placebo | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period | Post Baseline DBP >105 mmHg | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period | Post Baseline DBP >105 mmHg | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period | Baseline SBP <80 mmHg | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period | Post Baseline SBP <80 mmHg | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period | Baseline SBP >165 mmHg | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period | Post Baseline DBP <40 mmHg | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period | Baseline DBP <40 mmHg | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period | Post Baseline SBP >165 mmHg | 0 Participants |
| Dutasteride 0.5 mg | Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period | Baseline DBP >105 mmHg | 0 Participants |
Secondary
Number of Participants With Treatment-related AEs in the Double-blind and Open-label Combined Periods
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment related AE included events which the investigator classified as having a reasonable possibility of being caused by the investigational product or whose classification was missing.
Time frame: 48 weeks
Population: Dutasteride DB/OL Combined population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Treatment-related AEs in the Double-blind and Open-label Combined Periods | 11 Participants |
Secondary
Number of Participants With Treatment-related AEs in the Double-blind Treatment Period
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment related AE included events which the investigator classified as having a reasonable possibilty of being caused by the investigational product or whose classification was missing.
Time frame: 24 weeks
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Treatment-related AEs in the Double-blind Treatment Period | 5 Participants |
| Dutasteride 0.5 mg | Number of Participants With Treatment-related AEs in the Double-blind Treatment Period | 11 Participants |
Secondary
Number of Participants With Treatment-related AEs in the Open-label Treatment Period
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment related AE included events which the investigator classified as having a reasonable possibilty of being caused by the investigational product or whose classification was missing.
Time frame: 24 weeks
Population: Open-Label Period Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Treatment-related AEs in the Open-label Treatment Period | 4 Participants |
| Dutasteride 0.5 mg | Number of Participants With Treatment-related AEs in the Open-label Treatment Period | 2 Participants |
Secondary
Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period
Assessment of suicidality were done through use of the Columbia Suicide Severity Rating Scale (C-SSRS) for suicidal ideation with the ratings 1 to 5 (1. wish to be dead, 2. Non-specific suicidal thoughts, 3..without intent, 4. with intent but no plan, 5. with plan and intent) and for suicidal behavior with the ratings 6 to 9 (6.Prep acts/behavior, 7.aborted attempt, 8. interrupted attempt and 9. actual attempt). C-SSRS was administered at Day 1, Week 12, Week 24, and the early withdrawal visit if applicable .
Time frame: 24 weeks
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period | Prep acts/behavior | 0 Participants |
| Placebo | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period | Without intent | 0 Participants |
| Placebo | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period | Aborted attempt | 0 Participants |
| Placebo | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period | Non-specific suicidal thoughts | 0 Participants |
| Placebo | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period | Interrupted attempt | 0 Participants |
| Placebo | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period | With intent but no plan | 0 Participants |
| Placebo | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period | Actual attempt | 0 Participants |
| Placebo | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period | With plan and intent | 0 Participants |
| Placebo | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period | Non-suicidal self injury behavior | 0 Participants |
| Placebo | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period | Wish to be dead | 0 Participants |
| Dutasteride 0.5 mg | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period | Non-suicidal self injury behavior | 0 Participants |
| Dutasteride 0.5 mg | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period | Without intent | 0 Participants |
| Dutasteride 0.5 mg | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period | Wish to be dead | 0 Participants |
| Dutasteride 0.5 mg | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period | With intent but no plan | 0 Participants |
| Dutasteride 0.5 mg | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period | With plan and intent | 0 Participants |
| Dutasteride 0.5 mg | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period | Prep acts/behavior | 0 Participants |
| Dutasteride 0.5 mg | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period | Aborted attempt | 0 Participants |
| Dutasteride 0.5 mg | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period | Interrupted attempt | 0 Participants |
| Dutasteride 0.5 mg | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period | Actual attempt | 0 Participants |
| Dutasteride 0.5 mg | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period | Non-specific suicidal thoughts | 0 Participants |
Secondary
Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period
Assessment of suicidality were done through use of the Columbia Suicide Severity Rating Scale (C-SSRS) for suicidal ideation with the ratings 1 to 5 (1. wish to be dead, 2. Non-specific suicidal thoughts, 3. without intent, 4. with intent but no plan, 5. with plan and intent) and for suicidal behavior with the ratings 6 to 9 (6.Prep acts/behavior, 7.aborted attempt, 8. interrupted attempt and 9. actual attempt). C-SSRS was administered at Day 1, Week 12, Week 24, and the early withdrawal visit if applicable .
Time frame: 24 weeks
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period | Wish to be dead | 0 Participants |
| Placebo | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period | Non-specific suicidal thoughts | 0 Participants |
| Placebo | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period | Without intent | 0 Participants |
| Placebo | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period | With intent but no plan | 0 Participants |
| Placebo | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period | With plan and intent | 0 Participants |
| Placebo | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period | Prep acts/behavior | 0 Participants |
| Placebo | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period | Aborted attempt | 0 Participants |
| Placebo | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period | Interrupted attempt | 0 Participants |
| Placebo | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period | Actual attempt | 0 Participants |
| Placebo | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period | Non-suicidal self injury behavior | 0 Participants |
| Dutasteride 0.5 mg | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period | Interrupted attempt | 0 Participants |
| Dutasteride 0.5 mg | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period | Wish to be dead | 0 Participants |
| Dutasteride 0.5 mg | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period | Prep acts/behavior | 0 Participants |
| Dutasteride 0.5 mg | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period | Non-specific suicidal thoughts | 0 Participants |
| Dutasteride 0.5 mg | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period | Non-suicidal self injury behavior | 0 Participants |
| Dutasteride 0.5 mg | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period | Without intent | 0 Participants |
| Dutasteride 0.5 mg | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period | Aborted attempt | 0 Participants |
| Dutasteride 0.5 mg | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period | With intent but no plan | 0 Participants |
| Dutasteride 0.5 mg | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period | Actual attempt | 0 Participants |
| Dutasteride 0.5 mg | Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period | With plan and intent | 0 Participants |