Benign Prostatic Hyperplasia
Conditions
Brief summary
This study is designed to compare safety and efficacy of monotherapy finasteride to combination therapy (finasteride and tamsulosin) in Asian men with benign prostatic hyperplasia (BPH) who are at least 50 years of age or older. The primary hypotheses are that concomitantly-dosed finasteride 5 mg and tamsulosin 0.2 mg will be superior with respect to BPH symptoms compared to monotherapy with finasteride 5 mg as measured by change from baseline on the International Prostate Symptoms Score (IPSS) and will be superior with respect to prostate volume reduction compared to montherapy with tamsulosin 0.2 mg as measured by percent change from baseline in prostate volume.
Interventions
DRUGTamsulosin
Tamsulosin 0.2 mg oral capsule taken once daily.
DRUGFinasteride
Finasteride 5 mg oral tablet taken once daily.
DRUGFinasteride-matching placebo
Matching placebo to finasteride 5 mg oral tablet taken once daily.
DRUGTamsulosin-matching placebo
Matching placebo to tamsulosin 0.2 mg oral capsule taken once daily.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Possess a clinical diagnosis of BPH. * Able to read, understand, and complete the study questionnaire.
Exclusion criteria
* History or recurrent evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with participation for the full duration of the study. * History of malignancy ≤ 5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer, including prostate cancer of any duration, evidence or suspicion of prostate cancer on a previous biopsy. * History of prostatic surgery or other invasive procedures to treat BPH or history of bladder neck obstruction, bladder cancer, and/or pelvic irradiation, urinary incontinence, recurrent urinary tract infection, urethral stricture, or bacterial prostatitis. * History of acute urinary retention (ie, inability to fully empty bladder). * Had invasive urinary bladder procedures (ie, cystoscopy) within 7 days prior to screening. * Had phytotherapy within 2 weeks of screening and may need phytotherapy during the study. * History of low blood pressure (orthostatic hypotension, hypotension \[supine blood pressure less than 90/70 mm Hg\]), unstable angina, or a cardiovascular or cerebral vascular event (ie, transient ischemic attack \[TIA\], stroke) within the previous 3 months prior to enrollment, OR a history of dizziness, vertigo or any other typical signs and symptoms of low blood pressure. * Recent history (ie, within the past year) or active addiction, abuse, misuse of and/or dependence on drugs and/or alcohol. * Use of herbal therapies that may impact the study (eg, Saw Palmetto) within 2 weeks of screening and/or is predicted to need herbal therapies during the study. Individuals currently taking herbal therapies may be eligible for study if willing to complete a 2-week washout period. * Use of finasteride or a drug with a similar action during the 12 months prior to study screening. Individuals treated for short periods with 5-alpha reductase inhibitors (5ARIs) or drugs with antiandrogenic properties within 12 months of screening may be eligible for study. * Use of a non-approved (investigational) drug within the last 4 weeks prior to enrollment, or current participation in another clinical study. * Allergic or intolerant to finasteride and/or tamsulosin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in International Prostate Symptom Score (IPSS) | Baseline and Month 12 | The IPSS is a self-administered questionnaire used to measure the severity of lower urinary tract symptoms among men suspected of having symptomatic Benign Prostatic Hyperplasia (BPH). The IPSS consists of 8 questions (7 urinary symptom questions + 1 quality of life question). The 7 symptom questions inquire about frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying and urgency. Each of the 7 questions has an ordered categorical response frame scored from 0 (not at all) to 5 (almost all the time). The total score is the sum of the 7 items and therefore has a range of 0 to 35. Higher scores indicate higher symptom severity. The quality of life question is a single global question rated on a scale of 0 (delighted) to 6 (terrible) asking the participant to rate how they feel about their current urinary symptom status. The IPSS-QoL question is not used in the calculation of the total symptom score. |
| Percent Change From Baseline in Prostate Volume | Baseline and Month 12 | Prostate volume was assessed by trans-rectal ultrasound (TRUS). |
| Number of Participants Who Experienced an Adverse Event | Up to 54 weeks | An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. |
| Number of Participants Who Discontinued Treatment Due to an Adverse Event | Up to 52 weeks | An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. |
Participant flow
Pre-assignment details
Prior to early study discontinuation, 3 sites were initiated and screened a total of 8 participants. Of the 8 participants, one participant was randomized to finasteride 5 mg once daily for 39 days.
Participants by arm
| Arm | Count |
|---|---|
| Finasteride Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together. | 1 |
| Tamsulosin Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together. | 0 |
| Finasteride and Tamsulosin Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together. | 0 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Study Terminated Early | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Finasteride | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change From Baseline in International Prostate Symptom Score (IPSS)
The IPSS is a self-administered questionnaire used to measure the severity of lower urinary tract symptoms among men suspected of having symptomatic Benign Prostatic Hyperplasia (BPH). The IPSS consists of 8 questions (7 urinary symptom questions + 1 quality of life question). The 7 symptom questions inquire about frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying and urgency. Each of the 7 questions has an ordered categorical response frame scored from 0 (not at all) to 5 (almost all the time). The total score is the sum of the 7 items and therefore has a range of 0 to 35. Higher scores indicate higher symptom severity. The quality of life question is a single global question rated on a scale of 0 (delighted) to 6 (terrible) asking the participant to rate how they feel about their current urinary symptom status. The IPSS-QoL question is not used in the calculation of the total symptom score.
Time frame: Baseline and Month 12
Population: Full Analysis Set (FAS) - population consists of all randomized participants who received at least one dose of study treatment, at least one post-randomization observation for the analysis endpoint, and baseline data for those analyses that require baseline data. As only one participant was randomized in the study, no analyses were performed.
Primary
Number of Participants Who Discontinued Treatment Due to an Adverse Event
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.
Time frame: Up to 52 weeks
Population: All Participants as Treated (APaT) - population consists of all randomized participants who received at least one dose of study treatment. As only one participant was randomized in the study, no analyses were performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Finasteride | Number of Participants Who Discontinued Treatment Due to an Adverse Event | 0 Participants |
Primary
Number of Participants Who Experienced an Adverse Event
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.
Time frame: Up to 54 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Finasteride | Number of Participants Who Experienced an Adverse Event | 0 Participants |
Primary
Percent Change From Baseline in Prostate Volume
Prostate volume was assessed by trans-rectal ultrasound (TRUS).
Time frame: Baseline and Month 12
Population: Full Analysis Set (FAS) - population consists of all randomized participants who received at least one dose of study treatment, at least one post-randomization observation for the analysis endpoint, and baseline data for those analyses that require baseline data. As only one participant was randomized in the study, no analyses were performed.