Alopecia
Conditions
Keywords
dutasteride, Androgenic alopecia, phase 3
Brief summary
The aim of this Phase III study is to compare the efficacy, safety and tolerability of dutasteride (0.5mg) with placebo for 6 months, in Korean male subjects with androgenetic alopecia in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Interventions
DRUGDutasteride 0.5mg oral tablets
Dutasteride
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* Rationale - The vertex area of the scalp will be evaluated during this study, therefore the inclusion criterion of Norwood Hamilton areas IIIv, IV or V ensures that subjects with vertex hair loss will be recruited in line with the primary efficacy endpoint of change in hair growth in the vertex. A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. Male out-patients aged 18-49 years, inclusive 2. Diagnosis of Male Pattern Hair Loss classified as type IIIv, IV, or V utilising the modified Norwood-Hamilton classification (Figure 1) (N.B. types IVa and Va are excluded) 3. Able to comprehend instructions and record required information 4. Will provide signed and dated written informed consent to participate in this investigation
Exclusion criteria
* A subject will not be eligible for inclusion in this study if any of the following criteria apply: 1. Evidence of hypogonadism defined as serum testosterone \< 250ng/dl and/or LH \>20mIU/ml Note: If the initial serum testosterone result is \< 250ng/dl and the LH value is normal, the test may be repeated once. Attempts should be made, where possible, to collect all samples in the morning hours. If the repeat testosterone result is \< 250ng/dl, the subject is not eligible for participation. 2. Greater than two times the upper limit of normal for ALT or AST, or a bilirubin greater than 2.0mg/dl (exception - subjects diagnosed with Gilbert's syndrome will be eligible to participate in the study) 3. Serum creatinine \>1.8mg/dl 4. Global scalp hair thinning, including occipital areas 5. Scarring of the scalp or any other condition or disease of the scalp or hair, including diseases of the hair shaft (e.g., uncontrolled seborrheic dermatitis, tinea infections, other causes of alopecia, prior hair transplants or scalp reductions, psoriatic dermatitis) and inability to discontinue use of hair weaving. 6. Subjects who use hair colourants/hair dyes, or have the remaining traces of colourants in their hair. Subjects must maintain their natural hair colour throughout the study. 7. Hair length in non-balding areas ≤2cm (3/4 inch) around the vertex region of the head. Subjects must maintain the same hairstyle throughout the study. 8. History of malignancy within the past five years, except basal cell or squamous cell carcinoma of the skin 9. Serum PSA level \> 2.0 ng/ml at screening visit. 10. Family history(Father, brothers) of prostate cancer. 11. Active unstable thyroid disease, including subjects on therapy for either hyperthyroidism or hypothyroidism unless their dose of thyroid medication has been stable for 3 months and serum TSH is normal 12. Hypersensitivity to any 5 AR inhibitor or drugs chemically related to the study medication 13. Use of finasteride or other 5 AR inhibitors within the 12 months prior to screening. 14. Previous use of dutasteride. 15. Use of phytotherapy (e.g. saw palmetto) within 8 weeks prior to screening. 16. Previous use of cytotoxic agents 17. Use of glucocorticoids (inhaled glucocorticoids are allowed; topical steroids are allowed provided that they are not used on the scalp) within the 3 months prior to screening 18. Use of the following during the 6 months prior to screening: * Minoxidil (oral or topical) * Drugs with anti-androgenic properties (e.g., cyproterone acetate, spironolactone, ketoconazole, flutamide, bicalutamide). Cimetidine cannot be used during the study but is not an excluded drug when used during the previous 6 months. * Topical estrogen, progesterone * Tamoxifen * Drugs potentially causing hypertrichosis (e.g., cyclosporine, diazoxide, phenytoin psoralens) * Anabolic steroids * Lithium and phenothiazines 17\. Concurrent or regular use during the 4 weeks prior to screening of topical agents to the scalp (e.g., anti-inflammatories) 18. Participation in any investigational or marketed drug trial within 30 days preceding the screening phase of this study. Participation in any other drug trial during the course of this study including the follow-up period. 19\. History or current evidence of drug or alcohol abuse within the 12 months prior screening 20. History of any illness (including psychiatric) which may impair the ability to provide informed consent or comply with study requirements 21. History of any unstable illness or condition that, in the opinion of the investigator, might confound the results or put the subject at risk. 22\. Subjects who are known to be HIV positive (status which includes subjects with AIDS) 23. Subjects who will not refrain from donating blood until completing the study follow-up period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months. | Baseline and 6 months | The Macrophotographic hair count method marks a 1-inch diameter circular area at the anterior leading edge of the vertex thinning area and then photographed. The photographs are enlarged and converted into dot maps and the dot maps are converted into total hair counts by means of personal computer-based scanners and imaging software. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | Month 3 and Month 6 | GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth. |
| Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? | Month 3 and Month 6 | GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth. |
| Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Month 3 and Month 6 | GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth. |
| Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? | Month 3 and Month 6 | GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth. |
| Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | Month 3 and Month 6 | GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth. |
| Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | Month 3 and Month 6 | GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth. |
| Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Month 3 and Month 6 | GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth. |
| Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Month 3 and Month 6 | GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth. |
| Investigator's Photographic Assessment of Improvement Distribution From Baseline | Month 3 and Month 6 | Improvement Distribution is based on the number of hairs per centimeters squared by macrophotographic conversion hair count. Score Range -3=greatly decreased to +3=greatly increased. 0=No change. |
| Investigator's Photographic Assessment of Improvements From Baseline Score | Month 3 and Month 6 | Improvement Distribution Score is based on the number of hairs per centimeters squared by macrophotographic conversion hair count. Score Range: -3 = greatly decreased to +3 = greatly increased. 0 = No change. |
| Panel Assessment of Improvement Distribution From Screening | Baseline to Month 3 and Baseline to Month 6 | Improvement Distribution is based on the number of hairs per centimeters squared by macrophotographic conversion hair count. Score Range -3=greatly decreased to +3=greatly increased. 0=No change. |
| The Percentage Change From Baseline in Dihydrotestosterone (DHT) at Month 3, 6, and 10 | Month 3, Month 6 and Month 10 | Mean percent change from Baseline for DHT. DHT was measured in pg/ml. Change from baseline = Month 3, 6, and 10 values minus baseline value. |
| The Percentage Change From Baseline in Testosterone at Month 3, 6, and 10 | Month 3, Month 6, and Month 10 | Mean percent change from Baseline for testosterone. Testosterone was measured in ng/ml. |
| Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | Baseline to Month 6 and Month 10 | Normal ranges: TSH, 0.25-3.50 µIU/mL; T4, 4.5-12.0 mg/dL; PSA, ≤4 ng/mL; DHT, males (m): prepuberty, \<0.1, adult, 0.25-0.75; females (f): prepuberty, \<0.03, premenopausal, 0.05-0.3, menopausal, \<0.03 ng/mL; T, m: 2.36-9.96; f: 0.08-0.86 ng/mL; LH, m: 1-8; f: follicular, 4-12; periovulatory, \>20; luteal 5-20; postmenopausal, \>10 IU/L. |
| Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months. | Baseline and Month 3 | The Macrophotographic hair count method marks a 1-inch diameter circular area at the anterior leading edge of the vertex thinning area and then photographed. The photographs are enlarged and converted into dot maps and the dot maps are converted into total hair counts by means of personal computer-based scanners and imaging software. |
| Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Baseline and Month 6 | Comparing Lab values and differences from Baseline to month 6 |
| Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. | Baseline and Month 6 | sGOT (AST)- serum Glutamic-Oxaloacetic Transaminase, sGPT (ALT) - serum Glutamic-Pyruvic Transaminase, Alkaline Phosphatase, Bilirubin(mg/dL) and Albumin(g/dL) |
| Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. | Baseline and Month 6 | Glucose, Creatinine, Ferritine (ug/L) and Zinc (Hmol/L) |
| Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Screening | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? |
| Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Baseline | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? |
| Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Month 3 | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? |
| Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Month 6 | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? |
| Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Month 10 | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? |
| Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Baseline to Month 6 | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively. |
| Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Baseline to Month 6 | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively. |
| Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Baseline to Month 6 | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively. |
| Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Baseline to Month 10 | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively. |
| Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Baseline to Month 10 | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively. |
| Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Baseline to Month 10 | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively. |
| Laboratory Values: Electrolytes Assessed at Baseline and 6 Months. | Baseline and Month 6 | Sodium, Potassium (mEq/L), and Bicarbonate |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dutasteride Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification. | 76 |
| Placebo Subjects who were given no Investigational product. | 77 |
| Total | 153 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Did not meet Eligibility Criteria | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Dutasteride | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 37.78 years STANDARD_DEVIATION 7.07 | 38.41 years STANDARD_DEVIATION 6.61 | 38.097 years STANDARD_DEVIATION 6.84 |
| Region of Enrollment Korea, Democratic People's Republic of | 76 participants | 77 participants | 153 participants 0 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 76 Participants | 77 Participants | 153 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 73 | 7 / 75 |
| serious Total, serious adverse events | 0 / — | 1 / — |
Outcome results
Primary
Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months.
The Macrophotographic hair count method marks a 1-inch diameter circular area at the anterior leading edge of the vertex thinning area and then photographed. The photographs are enlarged and converted into dot maps and the dot maps are converted into total hair counts by means of personal computer-based scanners and imaging software.
Time frame: Baseline and 6 months
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dutasteride | Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months. | Month 6 | 162.27 hair count per centimeters squared | Standard Deviation 38.52 |
| Dutasteride | Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months. | Baseline | 148.14 hair count per centimeters squared | Standard Deviation 36.27 |
| Dutasteride | Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months. | Change from Baseline - Month 6 | 12.21 hair count per centimeters squared | Standard Deviation 23.6 |
| Placebo | Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months. | Baseline | 144.27 hair count per centimeters squared | Standard Deviation 32.33 |
| Placebo | Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months. | Month 6 | 149.57 hair count per centimeters squared | Standard Deviation 34.44 |
| Placebo | Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months. | Change from Baseline - Month 6 | 4.67 hair count per centimeters squared | Standard Deviation 16.81 |
Comparison: Month 6 - Baselinep-value: 0.031995% CI: [0.75, 14.33]t-test, 2 sided
Secondary
Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months.
The Macrophotographic hair count method marks a 1-inch diameter circular area at the anterior leading edge of the vertex thinning area and then photographed. The photographs are enlarged and converted into dot maps and the dot maps are converted into total hair counts by means of personal computer-based scanners and imaging software.
Time frame: Baseline and Month 3
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dutasteride | Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months. | Baseline | 148.14 hair count per centimeters squared | Standard Deviation 36.27 |
| Dutasteride | Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months. | Month 3 | 160.19 hair count per centimeters squared | Standard Deviation 36.73 |
| Dutasteride | Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months. | Change from Baseline - Month 3 | 7.58 hair count per centimeters squared | Standard Deviation 22.7 |
| Placebo | Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months. | Baseline | 144.27 hair count per centimeters squared | Standard Deviation 32.33 |
| Placebo | Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months. | Month 3 | 154.50 hair count per centimeters squared | Standard Deviation 36.87 |
| Placebo | Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months. | Change from Baseline - Month 3 | 10.24 hair count per centimeters squared | Standard Deviation 19.02 |
Secondary
Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10.
Normal ranges: TSH, 0.25-3.50 µIU/mL; T4, 4.5-12.0 mg/dL; PSA, ≤4 ng/mL; DHT, males (m): prepuberty, \<0.1, adult, 0.25-0.75; females (f): prepuberty, \<0.03, premenopausal, 0.05-0.3, menopausal, \<0.03 ng/mL; T, m: 2.36-9.96; f: 0.08-0.86 ng/mL; LH, m: 1-8; f: follicular, 4-12; periovulatory, \>20; luteal 5-20; postmenopausal, \>10 IU/L.
Time frame: Baseline to Month 6 and Month 10
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint. LH was only assessed at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | PSA - Month 6 - Abnormal | 0 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | T4 - Baseline - Normal | 73 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | PSA - Month 10 - Normal | 72 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | T4 - Baseline - Abnormal | 0 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | TSH - Baseline - Abnormal | 3 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | DHT - Screening - Normal | 72 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | T4 - Month 6 - Normal | 70 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | DHT - Screening - Abnormal | 1 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | PSA - Month 10 - Abnormal | 0 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | DHT - Month 6 - Normal | 69 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | T4 - Month 6 - Abnormal | 0 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | DHT - Month 6 - Abnormal | 1 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | TSH - Month 6 - Abnormal | 0 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | DHT - Month 10 - Normal | 70 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | DHT - Month 10 - Abnormal | 2 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | T4 - Month 10 - Normal | 72 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | Testosterone - Screening - Normal | 73 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | TSH - Month 6 - Normal | 70 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | Testosterone - Screening - Abnormal | 0 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | T4 - Month 10 - Abnormal | 0 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | Testosterone - Month 6 - Normal | 67 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | TSH - Month 10 - Normal | 71 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | Testosterone - Month 6 - Abnormal | 3 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | TSH - Baseline - Normal | 70 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | Testosterone - Month 10 - Normal | 69 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | PSA - Screening - Abnormal | 0 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | Testosterone - Month 10 - Abnormal | 3 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | TSH - Month 10 - Abnormal | 1 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | LH - Baseline - Normal | 67 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | PSA - Month 6 - Normal | 70 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | LH - Baseline - Abnormal | 6 Participants |
| Dutasteride | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | PSA - Screening - Normal | 73 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | LH - Baseline - Abnormal | 11 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | T4 - Baseline - Normal | 75 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | DHT - Month 10 - Normal | 72 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | TSH - Baseline - Normal | 75 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | TSH - Month 6 - Normal | 69 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | TSH - Month 6 - Abnormal | 4 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | TSH - Month 10 - Normal | 74 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | TSH - Month 10 - Abnormal | 1 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | T4 - Baseline - Abnormal | 0 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | T4 - Month 6 - Normal | 71 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | T4 - Month 6 - Abnormal | 2 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | T4 - Month 10 - Normal | 74 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | T4 - Month 10 - Abnormal | 1 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | PSA - Screening - Normal | 75 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | PSA - Screening - Abnormal | 0 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | PSA - Month 6 - Normal | 73 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | PSA - Month 6 - Abnormal | 0 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | PSA - Month 10 - Normal | 75 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | PSA - Month 10 - Abnormal | 0 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | DHT - Screening - Normal | 74 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | DHT - Screening - Abnormal | 1 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | DHT - Month 6 - Normal | 69 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | DHT - Month 6 - Abnormal | 4 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | DHT - Month 10 - Abnormal | 3 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | Testosterone - Screening - Normal | 74 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | Testosterone - Screening - Abnormal | 1 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | Testosterone - Month 6 - Normal | 71 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | Testosterone - Month 6 - Abnormal | 2 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | Testosterone - Month 10 - Normal | 74 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | Testosterone - Month 10 - Abnormal | 1 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | LH - Baseline - Normal | 64 Participants |
| Placebo | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | TSH - Baseline - Abnormal | 0 Participants |
Secondary
Investigator's Photographic Assessment of Improvement Distribution From Baseline
Improvement Distribution is based on the number of hairs per centimeters squared by macrophotographic conversion hair count. Score Range -3=greatly decreased to +3=greatly increased. 0=No change.
Time frame: Month 3 and Month 6
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride | Investigator's Photographic Assessment of Improvement Distribution From Baseline | Greatly decreased (Month 3) | 0 Participants |
| Dutasteride | Investigator's Photographic Assessment of Improvement Distribution From Baseline | Moderately increased (Month 3) | 8 Participants |
| Dutasteride | Investigator's Photographic Assessment of Improvement Distribution From Baseline | Moderately decreased (Month 3) | 1 Participants |
| Dutasteride | Investigator's Photographic Assessment of Improvement Distribution From Baseline | Slightly decreased (Month 3) | 0 Participants |
| Dutasteride | Investigator's Photographic Assessment of Improvement Distribution From Baseline | No Change (Month 3) | 28 Participants |
| Dutasteride | Investigator's Photographic Assessment of Improvement Distribution From Baseline | Slightly increased (Month 3) | 35 Participants |
| Dutasteride | Investigator's Photographic Assessment of Improvement Distribution From Baseline | Greatly increased (Month 3) | 1 Participants |
| Dutasteride | Investigator's Photographic Assessment of Improvement Distribution From Baseline | Greatly decreased (Month 6) | 0 Participants |
| Dutasteride | Investigator's Photographic Assessment of Improvement Distribution From Baseline | Moderately decreased (Month 6) | 0 Participants |
| Dutasteride | Investigator's Photographic Assessment of Improvement Distribution From Baseline | Slightly decreased (Month 6) | 4 Participants |
| Dutasteride | Investigator's Photographic Assessment of Improvement Distribution From Baseline | No Change (Month 6) | 24 Participants |
| Dutasteride | Investigator's Photographic Assessment of Improvement Distribution From Baseline | Slightly increased (Month 6) | 31 Participants |
| Dutasteride | Investigator's Photographic Assessment of Improvement Distribution From Baseline | Moderately increased (Month 6) | 12 Participants |
| Dutasteride | Investigator's Photographic Assessment of Improvement Distribution From Baseline | Greatly increased (Month 6) | 2 Participants |
| Placebo | Investigator's Photographic Assessment of Improvement Distribution From Baseline | No Change (Month 6) | 36 Participants |
| Placebo | Investigator's Photographic Assessment of Improvement Distribution From Baseline | Greatly decreased (Month 6) | 0 Participants |
| Placebo | Investigator's Photographic Assessment of Improvement Distribution From Baseline | Greatly decreased (Month 3) | 0 Participants |
| Placebo | Investigator's Photographic Assessment of Improvement Distribution From Baseline | Moderately increased (Month 6) | 1 Participants |
| Placebo | Investigator's Photographic Assessment of Improvement Distribution From Baseline | Moderately decreased (Month 3) | 1 Participants |
| Placebo | Investigator's Photographic Assessment of Improvement Distribution From Baseline | Moderately decreased (Month 6) | 8 Participants |
| Placebo | Investigator's Photographic Assessment of Improvement Distribution From Baseline | Slightly decreased (Month 3) | 13 Participants |
| Placebo | Investigator's Photographic Assessment of Improvement Distribution From Baseline | Slightly increased (Month 6) | 14 Participants |
| Placebo | Investigator's Photographic Assessment of Improvement Distribution From Baseline | No Change (Month 3) | 30 Participants |
| Placebo | Investigator's Photographic Assessment of Improvement Distribution From Baseline | Slightly decreased (Month 6) | 16 Participants |
| Placebo | Investigator's Photographic Assessment of Improvement Distribution From Baseline | Slightly increased (Month 3) | 30 Participants |
| Placebo | Investigator's Photographic Assessment of Improvement Distribution From Baseline | Moderately increased (Month 3) | 1 Participants |
| Placebo | Investigator's Photographic Assessment of Improvement Distribution From Baseline | Greatly increased (Month 6) | 0 Participants |
| Placebo | Investigator's Photographic Assessment of Improvement Distribution From Baseline | Greatly increased (Month 3) | 0 Participants |
Secondary
Investigator's Photographic Assessment of Improvements From Baseline Score
Improvement Distribution Score is based on the number of hairs per centimeters squared by macrophotographic conversion hair count. Score Range: -3 = greatly decreased to +3 = greatly increased. 0 = No change.
Time frame: Month 3 and Month 6
Population: Per Protocol Population (PP) defined as subjects in the ITT population taking study medication for 6 month and no identified as a major protocol violator.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dutasteride | Investigator's Photographic Assessment of Improvements From Baseline Score | Month 3 Mean Score | 0.78 units on a scale | Standard Deviation 0.79 |
| Dutasteride | Investigator's Photographic Assessment of Improvements From Baseline Score | Month 6 Mean Score | 0.88 units on a scale | Standard Deviation 0.86 |
| Placebo | Investigator's Photographic Assessment of Improvements From Baseline Score | Month 3 Mean Score | 0.19 units on a scale | Standard Deviation 0.78 |
| Placebo | Investigator's Photographic Assessment of Improvements From Baseline Score | Month 6 Mean Score | -0.30 units on a scale | Standard Deviation 0.85 |
Secondary
Laboratory Values: Electrolytes Assessed at Baseline and 6 Months.
Sodium, Potassium (mEq/L), and Bicarbonate
Time frame: Baseline and Month 6
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dutasteride | Laboratory Values: Electrolytes Assessed at Baseline and 6 Months. | Potassium (mEq/L) - Month 6 | 4.25 mmol/L | Standard Deviation 0.32 |
| Dutasteride | Laboratory Values: Electrolytes Assessed at Baseline and 6 Months. | Bicarbonate - Baseline | 27.66 mmol/L | Standard Deviation 2.19 |
| Dutasteride | Laboratory Values: Electrolytes Assessed at Baseline and 6 Months. | Bicarbonate - Month 6 | 26.61 mmol/L | Standard Deviation 2.12 |
| Dutasteride | Laboratory Values: Electrolytes Assessed at Baseline and 6 Months. | Sodium - Baseline | 141.23 mmol/L | Standard Deviation 1.72 |
| Dutasteride | Laboratory Values: Electrolytes Assessed at Baseline and 6 Months. | Sodium - Month 6 | 141.54 mmol/L | Standard Deviation 2.01 |
| Dutasteride | Laboratory Values: Electrolytes Assessed at Baseline and 6 Months. | Potassium (mEq/L) - Baseline | 4.22 mmol/L | Standard Deviation 0.31 |
| Placebo | Laboratory Values: Electrolytes Assessed at Baseline and 6 Months. | Sodium - Month 6 | 141.58 mmol/L | Standard Deviation 1.65 |
| Placebo | Laboratory Values: Electrolytes Assessed at Baseline and 6 Months. | Potassium (mEq/L) - Month 6 | 4.29 mmol/L | Standard Deviation 0.26 |
| Placebo | Laboratory Values: Electrolytes Assessed at Baseline and 6 Months. | Sodium - Baseline | 141.41 mmol/L | Standard Deviation 1.62 |
| Placebo | Laboratory Values: Electrolytes Assessed at Baseline and 6 Months. | Bicarbonate - Baseline | 28.23 mmol/L | Standard Deviation 2.28 |
| Placebo | Laboratory Values: Electrolytes Assessed at Baseline and 6 Months. | Potassium (mEq/L) - Baseline | 4.34 mmol/L | Standard Deviation 0.33 |
| Placebo | Laboratory Values: Electrolytes Assessed at Baseline and 6 Months. | Bicarbonate - Month 6 | 27.08 mmol/L | Standard Deviation 2.3 |
Secondary
Laboratory Values: Hematology Assessed at Baseline and 6 Months.
Comparing Lab values and differences from Baseline to month 6
Time frame: Baseline and Month 6
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dutasteride | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Basophils - Baseline | 0.48 thousands/microliter | Standard Deviation 0.28 |
| Dutasteride | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Monocytes - Baseline | 7.03 thousands/microliter | Standard Deviation 1.64 |
| Dutasteride | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | WBC - Baseline | 6898.49 thousands/microliter | Standard Deviation 1991.34 |
| Dutasteride | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | WBC - Month 6 | 6463.61 thousands/microliter | Standard Deviation 1421.58 |
| Dutasteride | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Neutrophils - Baseline | 53.46 thousands/microliter | Standard Deviation 9.17 |
| Dutasteride | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Neutrophils - Month 6 | 52.47 thousands/microliter | Standard Deviation 8.46 |
| Dutasteride | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Lymphocytes - Baseline | 35.96 thousands/microliter | Standard Deviation 8.03 |
| Dutasteride | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Lymphocytes - Month 6 | 36.96 thousands/microliter | Standard Deviation 7.61 |
| Dutasteride | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Monocytes - Month 6 | 7.08 thousands/microliter | Standard Deviation 1.39 |
| Dutasteride | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Eosinophils - Baseline | 2.81 thousands/microliter | Standard Deviation 2.34 |
| Dutasteride | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Eosinophils - Month 6 | 2.75 thousands/microliter | Standard Deviation 2.08 |
| Dutasteride | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Basophils - Month 6 | 0.50 thousands/microliter | Standard Deviation 0.21 |
| Dutasteride | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Platelets - Baseline | 249.63 thousands/microliter | Standard Deviation 52.79 |
| Dutasteride | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Platelets - Month 6 | 243.69 thousands/microliter | Standard Deviation 46.03 |
| Dutasteride | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Hemoglobin (%)- Baseline | 15.44 thousands/microliter | Standard Deviation 1.17 |
| Dutasteride | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Hemoglobin (%) - Month 6 | 15.41 thousands/microliter | Standard Deviation 1.1 |
| Dutasteride | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | MCV (fL)- Baseline | 92.12 thousands/microliter | Standard Deviation 3.31 |
| Dutasteride | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | MCV (fL) - Month 6 | 91.57 thousands/microliter | Standard Deviation 3.51 |
| Placebo | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Platelets - Month 6 | 240.26 thousands/microliter | Standard Deviation 50.9 |
| Placebo | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Eosinophils - Month 6 | 2.99 thousands/microliter | Standard Deviation 2.21 |
| Placebo | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Eosinophils - Baseline | 2.69 thousands/microliter | Standard Deviation 1.71 |
| Placebo | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | MCV (fL) - Month 6 | 91.44 thousands/microliter | Standard Deviation 3.88 |
| Placebo | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | WBC - Baseline | 6336.93 thousands/microliter | Standard Deviation 1815 |
| Placebo | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Basophils - Baseline | 0.52 thousands/microliter | Standard Deviation 0.28 |
| Placebo | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | WBC - Month 6 | 6387.03 thousands/microliter | Standard Deviation 1828.81 |
| Placebo | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Hemoglobin (%)- Baseline | 15.54 thousands/microliter | Standard Deviation 0.88 |
| Placebo | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Neutrophils - Baseline | 53.52 thousands/microliter | Standard Deviation 8.63 |
| Placebo | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Basophils - Month 6 | 0.51 thousands/microliter | Standard Deviation 0.26 |
| Placebo | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Neutrophils - Month 6 | 52.90 thousands/microliter | Standard Deviation 8.51 |
| Placebo | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | MCV (fL)- Baseline | 91.89 thousands/microliter | Standard Deviation 4.06 |
| Placebo | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Lymphocytes - Baseline | 35.87 thousands/microliter | Standard Deviation 8.28 |
| Placebo | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Platelets - Baseline | 250.19 thousands/microliter | Standard Deviation 53.67 |
| Placebo | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Lymphocytes - Month 6 | 36.03 thousands/microliter | Standard Deviation 8.19 |
| Placebo | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Monocytes - Baseline | 7.03 thousands/microliter | Standard Deviation 1.8 |
| Placebo | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Hemoglobin (%) - Month 6 | 15.46 thousands/microliter | Standard Deviation 0.86 |
| Placebo | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Monocytes - Month 6 | 7.14 thousands/microliter | Standard Deviation 1.75 |
Secondary
Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months.
sGOT (AST)- serum Glutamic-Oxaloacetic Transaminase, sGPT (ALT) - serum Glutamic-Pyruvic Transaminase, Alkaline Phosphatase, Bilirubin(mg/dL) and Albumin(g/dL)
Time frame: Baseline and Month 6
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dutasteride | Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. | Alkaline Phosphatase - Month 6 | 85.51 IU/L | Standard Deviation 33.09 |
| Dutasteride | Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. | ALT(SGPT) - Baseline | 29.79 IU/L | Standard Deviation 15.11 |
| Dutasteride | Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. | Bilirubin (mg/dL) - Baseline | 0.78 IU/L | Standard Deviation 0.32 |
| Dutasteride | Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. | AST(SGOT) - Month 6 | 25.88 IU/L | Standard Deviation 10.55 |
| Dutasteride | Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. | Bilirubin (mg/dL) - Month 6 | 0.80 IU/L | Standard Deviation 0.32 |
| Dutasteride | Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. | ALT(SGPT) - Month 6 | 34.00 IU/L | Standard Deviation 25.79 |
| Dutasteride | Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. | Albumin (g/dL) - Baseline | 4.66 IU/L | Standard Deviation 0.22 |
| Dutasteride | Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. | Alkaline Phosphatase - Baseline | 87.34 IU/L | Standard Deviation 40.14 |
| Dutasteride | Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. | Albumin (g/dL) - Month 6 | 4.64 IU/L | Standard Deviation 0.21 |
| Dutasteride | Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. | AST(SGOT) - Baseline | 23.10 IU/L | Standard Deviation 6.77 |
| Placebo | Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. | Albumin (g/dL) - Month 6 | 4.60 IU/L | Standard Deviation 0.24 |
| Placebo | Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. | AST(SGOT) - Baseline | 22.80 IU/L | Standard Deviation 6.14 |
| Placebo | Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. | AST(SGOT) - Month 6 | 25.11 IU/L | Standard Deviation 9.51 |
| Placebo | Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. | ALT(SGPT) - Baseline | 26.91 IU/L | Standard Deviation 12.36 |
| Placebo | Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. | Alkaline Phosphatase - Baseline | 85.79 IU/L | Standard Deviation 46.15 |
| Placebo | Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. | Alkaline Phosphatase - Month 6 | 84.24 IU/L | Standard Deviation 42.44 |
| Placebo | Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. | Bilirubin (mg/dL) - Baseline | 0.71 IU/L | Standard Deviation 0.28 |
| Placebo | Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. | Bilirubin (mg/dL) - Month 6 | 0.79 IU/L | Standard Deviation 0.31 |
| Placebo | Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. | Albumin (g/dL) - Baseline | 4.60 IU/L | Standard Deviation 0.25 |
| Placebo | Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. | ALT(SGPT) - Month 6 | 30.47 IU/L | Standard Deviation 18.81 |
Secondary
Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months.
Glucose, Creatinine, Ferritine (ug/L) and Zinc (Hmol/L)
Time frame: Baseline and Month 6
Population: Intent to Treat(ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dutasteride | Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. | Ferritine (ug/L) - Month 6 | 109.61 mg/dL | Standard Deviation 64.29 |
| Dutasteride | Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. | Glucose - Baseline | 104.48 mg/dL | Standard Deviation 25.32 |
| Dutasteride | Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. | Glucose - Month 6 | 104.49 mg/dL | Standard Deviation 24.45 |
| Dutasteride | Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. | Creatinine - Baseline | 1.03 mg/dL | Standard Deviation 0.14 |
| Dutasteride | Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. | Creatinine - Month 6 | 1.05 mg/dL | Standard Deviation 0.11 |
| Dutasteride | Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. | Ferritine (ug/L) - Baseline | 100.21 mg/dL | Standard Deviation 55.11 |
| Dutasteride | Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. | Zinc (Hmol/L) - Baseline | 111.19 mg/dL | Standard Deviation 35.35 |
| Dutasteride | Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. | Zinc (Hmol/L) - Month 6 | 118.07 mg/dL | Standard Deviation 40.75 |
| Placebo | Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. | Zinc (Hmol/L) - Month 6 | 113.87 mg/dL | Standard Deviation 39.8 |
| Placebo | Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. | Ferritine (ug/L) - Month 6 | 132.36 mg/dL | Standard Deviation 87.91 |
| Placebo | Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. | Creatinine - Month 6 | 1.06 mg/dL | Standard Deviation 0.14 |
| Placebo | Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. | Glucose - Baseline | 101.56 mg/dL | Standard Deviation 16.17 |
| Placebo | Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. | Zinc (Hmol/L) - Baseline | 112.66 mg/dL | Standard Deviation 45.62 |
| Placebo | Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. | Glucose - Month 6 | 106.31 mg/dL | Standard Deviation 20.82 |
| Placebo | Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. | Ferritine (ug/L) - Baseline | 131.91 mg/dL | Standard Deviation 77.74 |
| Placebo | Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. | Creatinine - Baseline | 1.03 mg/dL | Standard Deviation 0.14 |
Secondary
Panel Assessment of Improvement Distribution From Screening
Improvement Distribution is based on the number of hairs per centimeters squared by macrophotographic conversion hair count. Score Range -3=greatly decreased to +3=greatly increased. 0=No change.
Time frame: Baseline to Month 3 and Baseline to Month 6
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride | Panel Assessment of Improvement Distribution From Screening | Greatly increased (Month 3) | 0 Participants |
| Dutasteride | Panel Assessment of Improvement Distribution From Screening | Slightly decreased (Month 3) | 3 Participants |
| Dutasteride | Panel Assessment of Improvement Distribution From Screening | Moderately decreased (Month 6) | 0 Participants |
| Dutasteride | Panel Assessment of Improvement Distribution From Screening | Greatly decreased (Month 3) | 0 Participants |
| Dutasteride | Panel Assessment of Improvement Distribution From Screening | Slightly decreased (Month 6) | 6 Participants |
| Dutasteride | Panel Assessment of Improvement Distribution From Screening | No change (Month 3) | 28 Participants |
| Dutasteride | Panel Assessment of Improvement Distribution From Screening | No Change (Month 6) | 40 Participants |
| Dutasteride | Panel Assessment of Improvement Distribution From Screening | Greatly decreased (Month 6) | 0 Participants |
| Dutasteride | Panel Assessment of Improvement Distribution From Screening | Slightly increased (Month 6) | 20 Participants |
| Dutasteride | Panel Assessment of Improvement Distribution From Screening | Slightly increased (Month 3) | 33 Participants |
| Dutasteride | Panel Assessment of Improvement Distribution From Screening | Moderately increased (Month 6) | 5 Participants |
| Dutasteride | Panel Assessment of Improvement Distribution From Screening | Moderately decreased (Month 3) | 1 Participants |
| Dutasteride | Panel Assessment of Improvement Distribution From Screening | Greatly increased (Month 6) | 2 Participants |
| Dutasteride | Panel Assessment of Improvement Distribution From Screening | Moderately increased (Month 3) | 8 Participants |
| Placebo | Panel Assessment of Improvement Distribution From Screening | Greatly increased (Month 6) | 0 Participants |
| Placebo | Panel Assessment of Improvement Distribution From Screening | Greatly decreased (Month 3) | 0 Participants |
| Placebo | Panel Assessment of Improvement Distribution From Screening | Moderately decreased (Month 3) | 0 Participants |
| Placebo | Panel Assessment of Improvement Distribution From Screening | Slightly decreased (Month 3) | 14 Participants |
| Placebo | Panel Assessment of Improvement Distribution From Screening | No change (Month 3) | 29 Participants |
| Placebo | Panel Assessment of Improvement Distribution From Screening | Slightly increased (Month 3) | 28 Participants |
| Placebo | Panel Assessment of Improvement Distribution From Screening | Moderately increased (Month 3) | 4 Participants |
| Placebo | Panel Assessment of Improvement Distribution From Screening | Greatly decreased (Month 6) | 1 Participants |
| Placebo | Panel Assessment of Improvement Distribution From Screening | Moderately decreased (Month 6) | 4 Participants |
| Placebo | Panel Assessment of Improvement Distribution From Screening | Slightly decreased (Month 6) | 29 Participants |
| Placebo | Panel Assessment of Improvement Distribution From Screening | No Change (Month 6) | 32 Participants |
| Placebo | Panel Assessment of Improvement Distribution From Screening | Slightly increased (Month 6) | 8 Participants |
| Placebo | Panel Assessment of Improvement Distribution From Screening | Moderately increased (Month 6) | 1 Participants |
| Placebo | Panel Assessment of Improvement Distribution From Screening | Greatly increased (Month 3) | 0 Participants |
Secondary
Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation
In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?
Time frame: Baseline
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Sex Drive - Small problem | 6 Participants |
| Dutasteride | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Ejaculation - Small problem | 3 Participants |
| Dutasteride | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Sex Drive - No Problem | 63 Participants |
| Dutasteride | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Sex Drive - Very small problem | 4 Participants |
| Dutasteride | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Sex Drive - Medium problem | 0 Participants |
| Dutasteride | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Sex Drive - Big problem | 0 Participants |
| Dutasteride | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Erection - No Problem | 64 Participants |
| Dutasteride | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Erection - Very small problem | 5 Participants |
| Dutasteride | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Erection - Small problem | 4 Participants |
| Dutasteride | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Erection - Medium problem | 0 Participants |
| Dutasteride | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Erection - Big problem | 0 Participants |
| Dutasteride | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Ejaculation - No Problem | 63 Participants |
| Dutasteride | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Ejaculation - Very small problem | 7 Participants |
| Dutasteride | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Ejaculation - Medium problem | 0 Participants |
| Dutasteride | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Ejaculation - Big problem | 0 Participants |
| Placebo | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Ejaculation - Medium problem | 0 Participants |
| Placebo | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Erection - Small problem | 7 Participants |
| Placebo | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Ejaculation - Very small problem | 5 Participants |
| Placebo | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Sex Drive - No Problem | 60 Participants |
| Placebo | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Erection - Medium problem | 1 Participants |
| Placebo | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Sex Drive - Very small problem | 5 Participants |
| Placebo | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Sex Drive - Small problem | 8 Participants |
| Placebo | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Ejaculation - Small problem | 7 Participants |
| Placebo | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Sex Drive - Medium problem | 1 Participants |
| Placebo | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Erection - Big problem | 0 Participants |
| Placebo | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Sex Drive - Big problem | 0 Participants |
| Placebo | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Ejaculation - Big problem | 0 Participants |
| Placebo | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Erection - No Problem | 60 Participants |
| Placebo | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Ejaculation - No Problem | 62 Participants |
| Placebo | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | Erection - Very small problem | 6 Participants |
Secondary
Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation
In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?
Time frame: Month 10
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Ejaculation - Small Problem | 4 Participants |
| Dutasteride | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Sex Drive - No Problem | 62 Participants |
| Dutasteride | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Sex Drive - Very Small Problem | 7 Participants |
| Dutasteride | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Sex Drive - Small Problem | 2 Participants |
| Dutasteride | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Sex Drive - Medium Problem | 1 Participants |
| Dutasteride | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Sex Drive - Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Erection - No Problem | 59 Participants |
| Dutasteride | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Erection - Very Small Problem | 9 Participants |
| Dutasteride | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Erection - Small Problem | 4 Participants |
| Dutasteride | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Erection - Medium Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Erection - Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Ejaculation - No Problem | 60 Participants |
| Dutasteride | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Ejaculation - Very Small Problem | 7 Participants |
| Dutasteride | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Ejaculation - Medium Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Ejaculation - Big Problem | 1 Participants |
| Placebo | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Ejaculation - Medium Problem | 2 Participants |
| Placebo | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Erection - Small Problem | 2 Participants |
| Placebo | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Sex Drive - No Problem | 62 Participants |
| Placebo | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Ejaculation - Very Small Problem | 10 Participants |
| Placebo | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Sex Drive - Very Small Problem | 6 Participants |
| Placebo | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Erection - Medium Problem | 2 Participants |
| Placebo | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Sex Drive - Small Problem | 4 Participants |
| Placebo | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Ejaculation - Small Problem | 1 Participants |
| Placebo | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Sex Drive - Medium Problem | 3 Participants |
| Placebo | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Erection - Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Sex Drive - Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Ejaculation - Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Erection - No Problem | 60 Participants |
| Placebo | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Ejaculation - No Problem | 62 Participants |
| Placebo | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | Erection - Very Small Problem | 11 Participants |
Secondary
Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation
In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?
Time frame: Month 3
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Ejaculation - Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Sex Drive - No Problem | 49 Participants |
| Dutasteride | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Sex Drive - Very small Problem | 12 Participants |
| Dutasteride | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Sex Drive - Small Problem | 5 Participants |
| Dutasteride | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Sex Drive - Medium Problem | 5 Participants |
| Dutasteride | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Sex Drive - Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Erection - No Problem | 52 Participants |
| Dutasteride | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Erection - Very Small Problem | 11 Participants |
| Dutasteride | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Erection - Small Problem | 2 Participants |
| Dutasteride | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Erection - Medium Problem | 6 Participants |
| Dutasteride | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Erection - Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Ejaculation - No Problem | 55 Participants |
| Dutasteride | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Ejaculation - Very Small Problem | 9 Participants |
| Dutasteride | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Ejaculation - Small Problem | 3 Participants |
| Dutasteride | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Ejaculation - Medium Problem | 4 Participants |
| Placebo | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Ejaculation - Big Problem | 1 Participants |
| Placebo | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Erection - Small Problem | 3 Participants |
| Placebo | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Sex Drive - No Problem | 59 Participants |
| Placebo | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Ejaculation - Very Small Problem | 8 Participants |
| Placebo | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Sex Drive - Very small Problem | 8 Participants |
| Placebo | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Erection - Medium Problem | 3 Participants |
| Placebo | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Sex Drive - Small Problem | 5 Participants |
| Placebo | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Ejaculation - Medium Problem | 2 Participants |
| Placebo | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Sex Drive - Medium Problem | 0 Participants |
| Placebo | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Erection - Big Problem | 1 Participants |
| Placebo | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Sex Drive - Big Problem | 1 Participants |
| Placebo | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Ejaculation - Small Problem | 3 Participants |
| Placebo | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Erection - No Problem | 56 Participants |
| Placebo | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Ejaculation - No Problem | 59 Participants |
| Placebo | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | Erection - Very Small Problem | 10 Participants |
Secondary
Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation
In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?
Time frame: Month 6
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Erection - Small Problem | 6 Participants |
| Dutasteride | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Erection - Medium Problem | 3 Participants |
| Dutasteride | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Sex Drive - No Problem | 56 Participants |
| Dutasteride | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Erection - Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Sex Drive - Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Ejaculation - No Problem | 58 Participants |
| Dutasteride | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Sex Drive - Small Problem | 7 Participants |
| Dutasteride | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Ejaculation - Very Small Problem | 8 Participants |
| Dutasteride | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Erection - No Problem | 57 Participants |
| Dutasteride | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Ejaculation - Small Problem | 4 Participants |
| Dutasteride | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Sex Drive - Very Small Problem | 7 Participants |
| Dutasteride | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Ejaculation - Medium Problem | 2 Participants |
| Dutasteride | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Erection - Very Small Problem | 6 Participants |
| Dutasteride | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Ejaculation - Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Sex Drive - Medium Problem | 2 Participants |
| Placebo | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Ejaculation - Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Sex Drive - No Problem | 59 Participants |
| Placebo | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Sex Drive - Very Small Problem | 6 Participants |
| Placebo | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Sex Drive - Small Problem | 8 Participants |
| Placebo | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Sex Drive - Medium Problem | 2 Participants |
| Placebo | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Sex Drive - Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Erection - No Problem | 58 Participants |
| Placebo | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Erection - Very Small Problem | 9 Participants |
| Placebo | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Erection - Medium Problem | 1 Participants |
| Placebo | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Erection - Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Ejaculation - No Problem | 59 Participants |
| Placebo | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Ejaculation - Very Small Problem | 8 Participants |
| Placebo | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Ejaculation - Small Problem | 6 Participants |
| Placebo | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Ejaculation - Medium Problem | 2 Participants |
| Placebo | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | Erection - Small Problem | 7 Participants |
Secondary
Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation
In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?
Time frame: Screening
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Erection - Very Small Problem | 7 Participants |
| Dutasteride | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Sex Drive - Very Small Problem | 5 Participants |
| Dutasteride | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Erection - Small Problem | 4 Participants |
| Dutasteride | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Sex Drive - Medium Problem | 4 Participants |
| Dutasteride | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Erection - Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Sex Drive - No Problem | 60 Participants |
| Dutasteride | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Ejaculation - No Problem | 64 Participants |
| Dutasteride | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Sex Drive - Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Ejaculation - Very Small Problem | 6 Participants |
| Dutasteride | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Sex Drive - Small Problem | 4 Participants |
| Dutasteride | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Ejaculation - Small Problem | 3 Participants |
| Dutasteride | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Ejaculation - Medium Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Erection - No Problem | 62 Participants |
| Dutasteride | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Ejaculation - Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Erection - Medium Problem | 0 Participants |
| Placebo | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Ejaculation - Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Sex Drive - No Problem | 58 Participants |
| Placebo | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Sex Drive - Very Small Problem | 5 Participants |
| Placebo | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Sex Drive - Small Problem | 9 Participants |
| Placebo | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Ejaculation - Small Problem | 7 Participants |
| Placebo | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Sex Drive - Medium Problem | 3 Participants |
| Placebo | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Sex Drive - Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Erection - No Problem | 60 Participants |
| Placebo | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Erection - Very Small Problem | 6 Participants |
| Placebo | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Erection - Medium Problem | 2 Participants |
| Placebo | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Erection - Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Ejaculation - No Problem | 63 Participants |
| Placebo | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Ejaculation - Very Small Problem | 4 Participants |
| Placebo | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Ejaculation - Medium Problem | 1 Participants |
| Placebo | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | Erection - Small Problem | 7 Participants |
Secondary
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation
In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively.
Time frame: Baseline to Month 10
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Very Small Problem shift to No Problem | 2 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Small Problem shift to Small Problem | 1 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | No Problem shift to Small Problem | 3 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Small Problem shift to Medium Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Small Problem shift to Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Very Small Problem shift to Very Small Problem | 5 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Medium Problem shift to No Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Medium Problem shift to Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Medium Problem shift to Very Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Very Small Problem shift to Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Medium Problem shift to Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | No Problem shift to Medium Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Medium Problem shift to Medium Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Very Small Problem shift to Medium Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | No Problem shift to Very Small problem | 2 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Big Problem shift to No Proble | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Very Small Problem shift to Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Big Problem shift to Very Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | No Problem shift to Big Problem | 1 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Big Problem shift to Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Small Problem shift to No Problem | 2 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Big Problem shift to Medium Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | No Problem shift to No Problem | 56 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Big Problem shift to Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Small Problem shift to Very Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Big Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | No Problem shift to No Problem | 56 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | No Problem shift to Very Small problem | 6 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | No Problem shift to Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | No Problem shift to Medium Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | No Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Very Small Problem shift to No Problem | 3 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Very Small Problem shift to Very Small Problem | 1 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Very Small Problem shift to Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Very Small Problem shift to Medium Problem | 1 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Very Small Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Small Problem shift to No Problem | 2 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Small Problem shift to Very Small Problem | 3 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Small Problem shift to Small Problem | 1 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Small Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Medium Problem shift to No Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Medium Problem shift to Very Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Medium Problem shift to Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Medium Problem shift to Medium Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Medium Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Big Problem shift to No Proble | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Big Problem shift to Very Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Big Problem shift to Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Big Problem shift to Medium Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | Small Problem shift to Medium Problem | 1 Participants |
Secondary
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection
In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively.
Time frame: Baseline to Month 10
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Small Problem shift to No Problem | 3 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Very Small Problem shift to Medium Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | No Problem shift to Small Problem | 3 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Very Small Problem shift to Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Big Problem shift to Medium Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Small Problem shift to Small Problem | 1 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | No Problem shift to Medium Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Small Problem shift to Medium Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Small Problem shift to Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Medium Problem shift to No Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | No Problem shift to Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Medium Problem shift to Very Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Big Problem shift to Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Medium Problem shift to Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Medium Problem shift to Medium Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Very Small Problem shift to No Problem | 2 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Medium Problem shift to Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Small Problem shift to Very Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Big Problem shift to No Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Very Small Problem shift to Very Small Problem | 3 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Big Problem shift to Very Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | No Problem shift to Very Small Problem | 6 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Big Problem shift to Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Very Small Problem shift to Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | No Problem shift to No Problem | 54 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Big Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Small Problem shift to No Problem | 2 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Small Problem shift to Very Small Problem | 2 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Small Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Medium Problem shift to Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Big Problem shift to Medium Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | No Problem shift to No Problem | 54 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | No Problem shift to Very Small Problem | 5 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | No Problem shift to Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | No Problem shift to Medium Problem | 1 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | No Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Very Small Problem shift to No Problem | 2 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Very Small Problem shift to Very Small Problem | 4 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Very Small Problem shift to Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Very Small Problem shift to Medium Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Very Small Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Small Problem shift to Small Problem | 2 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Small Problem shift to Medium Problem | 1 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Medium Problem shift to No Problem | 1 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Medium Problem shift to Very Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Medium Problem shift to Medium Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Medium Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Big Problem shift to No Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Big Problem shift to Very Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | Big Problem shift to Small Problem | 0 Participants |
Secondary
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive
In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively.
Time frame: Baseline to Month 10
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Big Problem shift to Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Big Problem shift to No Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | No Problem shift to No Problem | 57 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | No Problem shift to Very Small Problem | 5 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | No Problem shift to Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | No Problem shift to Medium Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | No Problem shift to Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Very Small Problem shift to No Problem | 2 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Very Small Problem shift to Very Small Problem | 1 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Very Small Problem shift to Small Problem | 1 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Very Small Problem shift to Medium Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Very Small Problem shift to Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Small Problem shift to No Problem | 3 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Small Problem shift to Very Small Problem | 1 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Small Problem shift to Small Problem | 1 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Small Problem shift to Medium Problem | 1 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Small Problem shift to Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Medium Problem shift to No Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Medium Problem shift to Very Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Medium Problem shift to Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Medium Problem shift to Medium Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Medium Problem shift to Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Big Problem shift to Very Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Big Problem shift to Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Big Problem shift to Medium Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Big Problem shift to Medium Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Small Problem shift to Very Small Problem | 3 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Big Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Medium Problem shift to Medium Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | No Problem shift to No Problem | 55 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Small Problem shift to Small Problem | 3 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | No Problem shift to Very Small Problem | 3 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Big Problem shift to Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | No Problem shift to Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Small Problem shift to Medium Problem | 1 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | No Problem shift to Medium Problem | 2 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Medium Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | No Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Small Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Very Small Problem shift to No Problem | 4 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Big Problem shift to No Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Very Small Problem shift to Very Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Medium Problem shift to No Problem | 1 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Very Small Problem shift to Small Problem | 1 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Medium Problem shift to Very Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Very Small Problem shift to Medium Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Big Problem shift to Very Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Very Small Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Medium Problem shift to Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | Small Problem shift to No Problem | 1 Participants |
Secondary
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation
In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively.
Time frame: Baseline to Month 6
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Small Problem shift to Small Problem | 1 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Very Small Problem shift to Very Small Problem | 3 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Small Problem shift to Medium Problem | 1 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | No Problem shift to Medium Problem | 1 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Small Problem shift to Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Very Small Problem shift to Small Problem | 1 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Medium Problem shift to No Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | No Problem shift to No Problem | 54 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Medium Problem shift to Very Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Very Small Problem shift to Medium Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Medium Problem shift to Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | No Problem shift to Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Medium Problem shift to Medium Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Very Small Problem shift to Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Medium Problem shift to Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Big Problem shift to No Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | No Problem shift to Small Problem | 2 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Big Problem shift to Very Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Small Problem shift to No Problem | 1 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Big Problem shift to Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Very Small Problem shift to No Problem | 3 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Big Problem shift to Medium Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Small Problem shift to Very Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Big Problem shift to Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | No Problem shift to Very Small Problem | 5 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Big Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | No Problem shift to No Problem | 54 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | No Problem shift to Very Small Problem | 5 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | No Problem shift to Small Problem | 3 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | No Problem shift to Medium Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | No Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Very Small Problem shift to No Problem | 3 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Very Small Problem shift to Very Small Problem | 1 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Very Small Problem shift to Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Very Small Problem shift to Medium Problem | 1 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Very Small Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Small Problem shift to No Problem | 1 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Small Problem shift to Very Small Problem | 2 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Small Problem shift to Small Problem | 3 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Small Problem shift to Medium Problem | 1 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Small Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Medium Problem shift to No Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Medium Problem shift to Very Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Medium Problem shift to Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Medium Problem shift to Medium Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Big Problem shift to No Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Big Problem shift to Very Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Big Problem shift to Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Big Problem shift to Medium Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | Medium Problem shift to Big Problem | 0 Participants |
Secondary
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection
In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively.
Time frame: Baseline to Month 6
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Medium Problem shift to Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Very Small Problem shift to Very Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Small Problem shift to Very Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Medium Problem shift to Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Big Problem shift to Medium Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | No Problem shift to No Problem | 53 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | No Problem shift to Very Small Problem | 6 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | No Problem shift to Small Problem | 3 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | No Problem shift to Medium Problem | 1 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | No Problem shift to Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Very Small Problem shift to No Problem | 2 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Very Small Problem shift to Small Problem | 2 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Very Small Problem shift to Medium Problem | 1 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Very Small Problem shift to Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Small Problem shift to No Problem | 2 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Small Problem shift to Small Problem | 1 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Small Problem shift to Medium Problem | 1 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Small Problem shift to Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Medium Problem shift to No Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Medium Problem shift to Very Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Medium Problem shift to Medium Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Big Problem shift to No Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Big Problem shift to Very Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Big Problem shift to Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Big Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Small Problem shift to No Problem | 1 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Small Problem shift to Very Small Problem | 1 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Very Small Problem shift to Very Small Problem | 3 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Very Small Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Medium Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Medium Problem shift to Medium Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Small Problem shift to Small Problem | 4 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Big Problem shift to Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Small Problem shift to Medium Problem | 1 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | No Problem shift to No Problem | 52 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Big Problem shift to No Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Small Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | No Problem shift to Small Problem | 3 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Big Problem shift to Medium Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | No Problem shift to Medium Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Medium Problem shift to No Problem | 1 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | No Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Big Problem shift to Very Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Very Small Problem shift to No Problem | 3 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Medium Problem shift to Very Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Very Small Problem shift to Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | No Problem shift to Very Small Problem | 5 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Very Small Problem shift to Medium Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Medium Problem shift to Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | Big Problem shift to Big Problem | 0 Participants |
Secondary
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive
In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively.
Time frame: Baseline to Month 6
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Medium Problem shift to Medium Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Small Problem shift to No Problem | 3 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Medium Problem shift to Very Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | No Problem shift to No Problem | 53 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | No Problem shift to Very Small Problem | 6 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | No Problem shift to Small Problem | 2 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | No Problem shift to Medium Problem | 1 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | No Problem shift to Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Very Small Problem shift to No Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Very Small Problem shift to Very Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Very Small Problem shift to Small Problem | 3 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Very Small Problem shift to Medium Problem | 1 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Very Small Problem shift to Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Small Problem shift to Very Small Problem | 1 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Small Problem shift to Small Problem | 2 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Small Problem shift to Medium Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Small Problem shift to Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Medium Problem shift to No Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Medium Problem shift to Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Medium Problem shift to Big Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Big Problem shift to No Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Big Problem shift to Very Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Big Problem shift to Small Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Big Problem shift to Medium Problem | 0 Participants |
| Dutasteride | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Big Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Medium Problem shift to Medium Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Small Problem shift to Very Small Problem | 2 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Medium Problem shift to No Problem | 1 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Big Problem shift to Medium Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Big Problem shift to Very Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Small Problem shift to Small Problem | 3 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | No Problem shift to No Problem | 52 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Medium Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | No Problem shift to Very Small Problem | 4 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Small Problem shift to Medium Problem | 2 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | No Problem shift to Small Problem | 4 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Big Problem shift to Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | No Problem shift to Medium Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Small Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Big Problem shift to No Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Very Small Problem shift to No Problem | 4 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Medium Problem shift to Very Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Very Small Problem shift to Very Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Big Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Very Small Problem shift to Small Problem | 1 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Medium Problem shift to Small Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Very Small Problem shift to Medium Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | No Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Very Small Problem shift to Big Problem | 0 Participants |
| Placebo | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | Small Problem shift to No Problem | 1 Participants |
Secondary
Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is?
GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.
Time frame: Month 3 and Month 6
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Not changed (Month 6) | 23 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Much worse (Month 6) | 0 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Slightly worse (Month 3) | 1 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Moderately worse (Month 6) | 1 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Much worse (Month 3) | 0 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Slightly worse (Month 6) | 2 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Not Changed (Month 3) | 36 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Moderately Better (Month 3) | 7 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Slightly Better (Month 6) | 26 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Moderately worse (Month 3) | 0 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Moderately Better (Month 6) | 11 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Much Better (Month 3) | 4 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Much Better (Month 6) | 10 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Slightly Better (Month 3) | 25 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Much Better (Month 6) | 0 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Slightly Better (Month 3) | 20 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Much worse (Month 3) | 0 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Moderately worse (Month 3) | 1 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Slightly worse (Month 3) | 4 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Not Changed (Month 3) | 47 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Moderately Better (Month 3) | 3 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Much Better (Month 3) | 0 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Much worse (Month 6) | 0 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Moderately worse (Month 6) | 0 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Slightly worse (Month 6) | 10 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Not changed (Month 6) | 33 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Slightly Better (Month 6) | 29 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Moderately Better (Month 6) | 3 Participants |
Secondary
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had?
GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.
Time frame: Month 3 and Month 6
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? | I agree(Month 3) | 62 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? | I strongly disagree (Month 6) | 0 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? | I disagree (Month 3) | 4 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? | I disagree (Month 6) | 3 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? | I strongly agree(Month 6) | 7 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? | No opinion either way (Month 6) | 3 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? | No opinion either way (Month 3) | 5 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? | I agree (Month 6) | 60 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? | I strongly disagree (Month 3) | 0 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? | I strongly agree (Month 3) | 2 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? | I strongly agree(Month 6) | 0 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? | I strongly disagree (Month 3) | 0 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? | I disagree (Month 3) | 8 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? | I agree(Month 3) | 56 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? | I strongly agree (Month 3) | 0 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? | I strongly disagree (Month 6) | 0 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? | I disagree (Month 6) | 8 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? | No opinion either way (Month 6) | 9 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? | I agree (Month 6) | 58 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? | No opinion either way (Month 3) | 11 Participants |
Secondary
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost?
GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.
Time frame: Month 3 and Month 6
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | Slightly less hair (Month 3) | 26 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | Much less hair (Month 6) | 9 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | Moderately less hair (Month 6) | 13 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | Slightly more hair (Month 3) | 1 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | Slightly less hair (Month 6) | 24 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | Moderately less hair (Month 3) | 8 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | The same amount of hair (Month 6) | 25 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | Moderately more hair (Month 3) | 1 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | Slightly more hair (Month 6) | 2 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | The same amount of hair (Month 3) | 32 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | Moderately more hair (Month 6) | 0 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | Much more hair (Month 3) | 0 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | Much more hair (Month 6) | 0 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | Much less hair (Month 3) | 5 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | Much more hair (Month 6) | 0 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | Much less hair (Month 6) | 7 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | Much less hair (Month 3) | 4 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | Moderately less hair (Month 3) | 7 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | Slightly less hair (Month 3) | 26 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | The same amount of hair (Month 3) | 36 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | Slightly more hair (Month 3) | 2 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | Moderately more hair (Month 3) | 0 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | Much more hair (Month 3) | 0 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | Moderately less hair (Month 6) | 8 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | Slightly less hair (Month 6) | 22 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | The same amount of hair (Month 6) | 35 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | Slightly more hair (Month 6) | 3 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | Moderately more hair (Month 6) | 0 Participants |
Secondary
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers?
GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.
Time frame: Month 3 and Month 6
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | Much less scalp (Month 6) | 0 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | The same amount of scalp (Month 3) | 20 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | Moderately less scalp (Month 6) | 0 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | Slightly more scalp (Month 3) | 25 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | Slightly less scalp (Month 6) | 2 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | Much less scalp (Month 3) | 1 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | The same amount of scalp (Month 6) | 22 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | Moderately more scalp (Month 3) | 15 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | Slightly more scalp (Month 6) | 17 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | Slightly less scalp (Month 3) | 3 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | Moderately more scalp (Month 6) | 28 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | Much more scalp (Month 3) | 7 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | Much more scalp (Month 6) | 4 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | Moderately less scalp (Month 3) | 2 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | Much more scalp (Month 6) | 1 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | Much less scalp (Month 3) | 1 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | Moderately less scalp (Month 3) | 3 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | Slightly less scalp (Month 3) | 14 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | Slightly more scalp (Month 3) | 23 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | Moderately more scalp (Month 3) | 7 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | Much more scalp (Month 3) | 3 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | Much less scalp (Month 6) | 2 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | Moderately less scalp (Month 6) | 5 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | Slightly less scalp (Month 6) | 21 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | The same amount of scalp (Month 6) | 28 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | Slightly more scalp (Month 6) | 17 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | Moderately more scalp (Month 6) | 1 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | The same amount of scalp (Month 3) | 24 Participants |
Secondary
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down?
GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.
Time frame: Month 3 and Month 6
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? | I strongly disagree (month 3) | 0 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? | I disagree (month 3) | 18 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? | No opinion either way (month 3) | 20 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? | I agree (month 3) | 34 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? | I strongly agree (month 3) | 1 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? | I strongly disagree (month 6) | 0 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? | I disagree (month 6) | 18 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? | No opinion either way (month 6) | 12 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? | I agree (month 6) | 40 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? | I strongly agree (month 6) | 3 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? | No opinion either way (month 6) | 17 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? | I strongly disagree (month 3) | 1 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? | I strongly disagree (month 6) | 0 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? | I disagree (month 3) | 30 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? | I strongly agree (month 6) | 2 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? | No opinion either way (month 3) | 13 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? | I disagree (month 6) | 27 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? | I agree (month 3) | 30 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? | I agree (month 6) | 29 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? | I strongly agree (month 3) | 1 Participants |
Secondary
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has?
GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.
Time frame: Month 3 and Month 6
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Stayed the same (Month 3) | 17 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Greatly decreased (Month 6) | 0 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Greatly decreased (Month 3) | 0 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Moderately decreased (Month 6) | 0 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Slightly increased (Month 3) | 26 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Slightly decreased (Month 6) | 0 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Stayed the same (Month 6) | 22 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Slightly decreased (Month 3) | 7 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Slightly increased (Month 6) | 22 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Moderately increased (Month 3) | 15 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Moderately increased (Month 6) | 23 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Moderately decreased (Month 3) | 2 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Greatly increased (Month 6) | 6 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Greatly increased (Month 3) | 6 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Greatly increased (Month 6) | 1 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Greatly decreased (Month 3) | 0 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Moderately decreased (Month 3) | 1 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Slightly decreased (Month 3) | 19 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Stayed the same (Month 3) | 21 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Slightly increased (Month 3) | 21 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Moderately increased (Month 3) | 10 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Greatly increased (Month 3) | 3 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Greatly decreased (Month 6) | 2 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Moderately decreased (Month 6) | 4 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Stayed the same (Month 6) | 26 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Slightly increased (Month 6) | 18 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Moderately increased (Month 6) | 2 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Slightly decreased (Month 6) | 22 Participants |
Secondary
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is?
GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.
Time frame: Month 3 and Month 6
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Moderately Worse (Month 6) | 0 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Much Better (Month 6) | 9 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Much Worse (Month 3) | 0 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Moderately Worse (Month 3) | 2 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Slightly Worse (Month 3) | 2 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Not Changed (Month 3) | 16 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Slightly Better (Month 3) | 28 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Moderately Better (Month 3) | 14 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Much Better (Month 3) | 11 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Much Worse (Month 6) | 0 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Slightly Worse (Month 6) | 0 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Not Changed (Month 6) | 21 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Slightly Better (Month 6) | 24 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Moderately Better (Month 6) | 19 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Slightly Worse (Month 6) | 20 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Moderately Worse (Month 6) | 2 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Moderately Better (Month 6) | 2 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Moderately Better (Month 3) | 9 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Slightly Better (Month 6) | 23 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Much Worse (Month 3) | 0 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Much Better (Month 3) | 4 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Moderately Worse (Month 3) | 1 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Not Changed (Month 6) | 25 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Slightly Worse (Month 3) | 9 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Much Worse (Month 6) | 1 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Not Changed (Month 3) | 28 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Much Better (Month 6) | 2 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Slightly Better (Month 3) | 24 Participants |
Secondary
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See?
GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.
Time frame: Month 3 and Month 6
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | Much more scalp (month 6) | 0 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | Much less scalp (month 6) | 9 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | The same amount of scalp (month 3) | 14 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | Moderately less scalp (month 6) | 16 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | Moderately less scalp (month 3) | 17 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | Slightly less scalp (month 6) | 26 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | Slightly more scalp (month 3) | 3 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | The same amount of scalp (month 6) | 20 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | Much less scalp (month 3) | 10 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | Slightly more scalp (month 6) | 1 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | Moderately more scalp (month 3) | 1 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | Moderately more scalp (month 6) | 1 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | Slightly less scalp (month 3) | 25 Participants |
| Dutasteride | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | Much more scalp (month 3) | 3 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | Much more scalp (month 6) | 1 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | Much less scalp (month 3) | 3 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | Moderately less scalp (month 3) | 11 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | Slightly less scalp (month 3) | 17 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | The same amount of scalp (month 3) | 26 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | Slightly more scalp (month 3) | 14 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | Moderately more scalp (month 3) | 4 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | Much more scalp (month 3) | 0 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | Much less scalp (month 6) | 2 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | Moderately less scalp (month 6) | 5 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | Slightly less scalp (month 6) | 15 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | The same amount of scalp (month 6) | 26 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | Slightly more scalp (month 6) | 22 Participants |
| Placebo | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | Moderately more scalp (month 6) | 4 Participants |
Secondary
The Percentage Change From Baseline in Dihydrotestosterone (DHT) at Month 3, 6, and 10
Mean percent change from Baseline for DHT. DHT was measured in pg/ml. Change from baseline = Month 3, 6, and 10 values minus baseline value.
Time frame: Month 3, Month 6 and Month 10
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dutasteride | The Percentage Change From Baseline in Dihydrotestosterone (DHT) at Month 3, 6, and 10 | % Change in DHT - Month 3 | -16.92 Percent change | Standard Deviation 54.14 |
| Dutasteride | The Percentage Change From Baseline in Dihydrotestosterone (DHT) at Month 3, 6, and 10 | % Change in DHT - Month 6 | -4.30 Percent change | Standard Deviation 38.73 |
| Dutasteride | The Percentage Change From Baseline in Dihydrotestosterone (DHT) at Month 3, 6, and 10 | % Change in DHT - Month 10 | 3.85 Percent change | Standard Deviation 44.34 |
| Placebo | The Percentage Change From Baseline in Dihydrotestosterone (DHT) at Month 3, 6, and 10 | % Change in DHT - Month 3 | -1.90 Percent change | Standard Deviation 47.58 |
| Placebo | The Percentage Change From Baseline in Dihydrotestosterone (DHT) at Month 3, 6, and 10 | % Change in DHT - Month 6 | 22.83 Percent change | Standard Deviation 45.3 |
| Placebo | The Percentage Change From Baseline in Dihydrotestosterone (DHT) at Month 3, 6, and 10 | % Change in DHT - Month 10 | 7.58 Percent change | Standard Deviation 50.28 |
Secondary
The Percentage Change From Baseline in Testosterone at Month 3, 6, and 10
Mean percent change from Baseline for testosterone. Testosterone was measured in ng/ml.
Time frame: Month 3, Month 6, and Month 10
Population: Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dutasteride | The Percentage Change From Baseline in Testosterone at Month 3, 6, and 10 | % Change in Testosterone - Month 3 | 18.78 Percent change | Standard Deviation 28.69 |
| Dutasteride | The Percentage Change From Baseline in Testosterone at Month 3, 6, and 10 | % Change in Testosterone - Month 6 | 8.15 Percent change | Standard Deviation 30.18 |
| Dutasteride | The Percentage Change From Baseline in Testosterone at Month 3, 6, and 10 | % Change in Testosterone - Month 10 | 12.18 Percent change | Standard Deviation 26.17 |
| Placebo | The Percentage Change From Baseline in Testosterone at Month 3, 6, and 10 | % Change in Testosterone - Month 3 | -5.27 Percent change | Standard Deviation 28.9 |
| Placebo | The Percentage Change From Baseline in Testosterone at Month 3, 6, and 10 | % Change in Testosterone - Month 6 | -6.59 Percent change | Standard Deviation 31.86 |
| Placebo | The Percentage Change From Baseline in Testosterone at Month 3, 6, and 10 | % Change in Testosterone - Month 10 | 0.99 Percent change | Standard Deviation 27.42 |