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The purpose of this study is to assess the safety and effectiveness of S-equol in men with benign prostatic hyperplasia.
The study is a phase 2a, randomized, double blind, multicenter, placebo controlled, parallel group, proof of concept study comparing the efficacy, safety, and acceptability of S-equol to placebo in patients with benign prostatic hyperplasia. The study objective is to examine a dose response of 3 dose levels of S equol versus placebo on prostate specific antigen concentrations in patients with benign prostatic hyperplasia. The safety of S-equol will be evaluated during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 150mg S-equol | Experimental |
| |
| 50mg S-equol | Experimental |
| |
| 10 mg S-equol | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-equol | Drug | 10mg S-equol 50mg S-equol, & 150mg S-equol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at Week 4 in Prostate Specific Antigen (PSA) Concentration. | Prostate specific antigen is considered to be the most sensitive measure of S-equol effects on the prostate, due to the expected effects of S-equol on the androgen receptor axis. In this proof-of-concept study, a population of 124 male subjects was estimated to achieve approximately 104 completed subjects (based on an estimated drop-out rate of 15%) to examine the dose-response compared to placebo. A sample size of 26 subjects in each treatment arm was considered to be adequate to observe a trend in this proof-of-concept study. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Prostate Volume From Baseline at Week 4 | Prostate size as measured by prostate volume as assessed by transrectal ultrasound. | 4 weeks |
| Change in Qmax From Baseline at Week 4 | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald Bergner, MD | Tampa Bay Medical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Affiliated Research Center | Huntsville | Alabama | 35801 | United States | ||
| South Florida Medical Research |
Not provided
Participants were recruited from 4 centers in Australia, 10 centers in India, and 8 centers in the United States from February 2010 to August 2015. The first participant was enrolled in August 2010, and the last participant was enrolled in August 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | S-equol 10 mg BID | Experimental: S-equol Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks. |
| FG001 | S-equol 50 mg BID | Experimental: S-equol Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks. |
| FG002 | S-equol 150 mg BID | Experimental: S-equol Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks. |
| FG003 | Placebo BID | Placebo Comparator: Placebo Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who took at least one (1) dose of investigational product were included in the baseline analysis population.
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| ID | Title | Description |
|---|---|---|
| BG000 | S-equol 10 mg BID | Experimental: S-equol Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks. |
| BG001 | S-equol 50 mg BID | Experimental: S-equol Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline at Week 4 in Prostate Specific Antigen (PSA) Concentration. | Prostate specific antigen is considered to be the most sensitive measure of S-equol effects on the prostate, due to the expected effects of S-equol on the androgen receptor axis. In this proof-of-concept study, a population of 124 male subjects was estimated to achieve approximately 104 completed subjects (based on an estimated drop-out rate of 15%) to examine the dose-response compared to placebo. A sample size of 26 subjects in each treatment arm was considered to be adequate to observe a trend in this proof-of-concept study. | All Participants who received at least 1 dose of study drug and who had a post-dose PSA assessment at Week 4. | Posted | Least Squares Mean | Standard Error | ng/mL | 4 weeks |
|
AEs were collected from the time of signing of the ICF through the Follow-up Visit (Visit 6) or Early Termination Visit (whichever occurred first), up to Day 56±2 days.
The investigator monitored and/or asked about or evaluated adverse events (AEs) using non-leading questions at each visit or evaluation. The occurrence of all AEs were documented in the Adverse Event Case Report Form.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | S-equol 10 mg BID | Experimental: S-equol Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks. At-risk Participants were subjects who received at least one dose of S-at any time during the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood pressure increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision Blurred | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rick Schwen, PhD, DABT, RAC / Vice President of Regulatory Affairs | Ausio Pharmaceuticals, LLC | 513-731-0222 | rick@ausiopharma.com |
Not provided
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D060754 | Equol |
| ID | Term |
|---|---|
| D007529 | Isoflavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D006574 |
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| Placebo | Drug | Placebo |
|
| Categorical Change in Qmax From Baseline at Week 4 | 4 weeks |
| Percent Change in Qmax From Baseline at Week 4 | 4 weeks |
| Change in Void Volume From Baseline at Week 4 | 4 weeks |
| Change in Post-Void Residual Volume From Baseline at Week 4 | 4 weeks |
| Change in in Dihydrotestosterone Concentration From Baseline at Week 4 | 4 weeks |
| Change in Luteinizing Hormone Concentration From Baseline at Week 4 | 4 weeks |
| Change in Total Testosterone Concentration From Baseline at Week 4 | 4 weeks |
| Participants Assessment of Nocturia at Week 4 | Participants were asked to rate their change in nocturia (number of times you wake from sleep to urinate) since the Baseline Visit. | 4 weeks |
| Investigators Assessment of Nocturia at Week 4 | Investigators were asked to rate participant's change in nocturia since the Baseline Visit. | 4 weeks |
| Change in I-PSS Total Score From Baseline at Week 4 | The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of 6 answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). The first seven questions of the I-PSS are identical to the questions appearing on the American Urological Association (AUA) Symptom Index which currently categorizes symptoms as follows: Mild (symptom score less than of equal to 7); Moderate (symptom score range 8-19); and Severe (symptom score range 20-35). A reduction in I-PSS Total Score is consistent with improvement in symptoms of BPH. | 4 weeks |
| Change in DAN Prostate Symptom Scale From Baseline at Week 4 | The questionnaire is made up of two kinds of questions: intensity of a symptom and bothersomeness of a symptom. Prostate symptoms are addressed in questions 1 - 12 and sexual function in questions 13 - 15. Patients indicate how intense/frequent (scoring 0, 1, 2, or 3; where 0 represents the best case and 3 the worst case) and how bothersome the symptom (scoring 0, 1, 2, or 3; where 0 is 'not at all' and 3 is 'very much'). DAN-PSS total and DAN-PSS total sexual function score were calculated by multiplying the frequency score by the trouble score of each symptom, and then adding the resulting figures. The possible values of DAN-PSS total ranged from 0 to 108 and of DAN-PSS total sexual function score ranged from 0 to 27. A reduction in DAN-PSS total and/or sexual function score is consistent with improved BPH symptoms/sexual functioning. | 4 weeks |
| Aventura |
| Florida |
| 33180 |
| United States |
| Tampa Bay Medical Research | Clearwater | Florida | 33761 | United States |
| Advanced Clinical Research | West Jordon | Utah | 84088 | United States |
| Clinical Research Associates of Tidewater | Norfolk | Virginia | 23507 | United States |
| Samved Hospital | Ahmedabad | India |
| M S Ramaiah Memorial Hospital | Bangalore | India |
| St. John's Medical College Hospital | Bangalore | India |
| G S Medical College and KEM Hospital | Delhi | India |
| Indraprastha Apollo Hospital | Delhi | India |
| V M Medical College and Safdarjung Hospital | Delhi | India |
| SMS Hospital | Jaipur | India |
| A J Hospital and Research Center | Mangalore | India |
| Inamdar Multispecialty Hospital | Pune | India |
| Ruby Hall Clinic | Pune | India |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG002 | S-equol 150 mg BID | Experimental: S-equol Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks. |
| BG003 | Placebo BID | Placebo Comparator: Placebo Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Prostate specific antigen (PSA) concentration | Participants who had taken at least one (1) dose of investigational product and had a baseline value of interest. | Mean | Standard Deviation | ng/mL |
|
| Prostate Volume | Participants who had taken at least one (1) dose of investigational product and had a baseline value of interest. | Mean | Standard Deviation | mL |
|
| Post Void Residual Urine Volume | Participants who had taken at least one (1) dose of investigational product and had a baseline value of interest. | Mean | Standard Deviation | mL |
|
| Qmax Result | Participants who had taken at least one (1) dose of investigational product and had a baseline value of interest. | Mean | Standard Deviation | mL/second |
|
| Void Volume | Participants who had taken at least one (1) dose of investigational product and had a baseline value of interest. | Mean | Standard Deviation | mL |
|
| Dihydrotestosterone | Participants who had taken at least one (1) dose of investigational product and had a baseline value of interest. | Mean | Standard Deviation | pg/mL |
|
| Luteinizing Hormone | Participants who had taken at least one (1) dose of investigational product and had a baseline value of interest. | Mean | Standard Deviation | IU/L |
|
| Testosterone, Total | Participants who had taken at least one (1) dose of investigational product and had a baseline value of interest. | Mean | Standard Deviation | nmol/L |
|
| Total International Prostate Symptom Score (I-PSS) | The I-PSS is based on the answers to 7 questions concerning urinary symptoms and one question concerning the quality of life. Each question concerning urinary symptoms allows the subject to choose 1 out of 6 answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can, therefore, range from 0 (asymptomatic) to 35 (very symptomatic). | Participants who had taken at least one (1) dose of investigational product and had a baseline value of interest. | Mean | Standard Deviation | units on a scale |
|
| Total Danish Prostatic Symptom Score (DAN-PSS-1) | The DAN-PSS-1 is a self-administered quality-of-life questionnaire comprising 12 questions related to lower urinary tract symptoms (bladder storage and voiding function), and 3 questions related to sexual function (symptom score). All answers for symptom and bothersomeness were classified in a 4-ranked scale from 0 (absence of symptoms or no impact on daily life) to 3 (the maximum severity of symptoms or impact on daily life). A weighted score was then calculated to give a total score that ranged from 0 to 108, where higher scores represented worsening symptoms and bothersomeness. | Participants who had taken at least one (1) dose of investigational product and had a baseline value of interest. | Mean | Standard Deviation | units on a scale |
|
| OG001 | S-equol 50 mg BID | Experimental: S-equol Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks. |
| OG002 | S-equol 150 mg BID | Experimental: S-equol Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks. |
| OG003 | Placebo BID | Placebo Comparator: Placebo Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks. |
|
|
|
| Secondary | Change in Prostate Volume From Baseline at Week 4 | Prostate size as measured by prostate volume as assessed by transrectal ultrasound. | All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest. | Posted | Mean | Standard Deviation | mL | 4 weeks |
|
|
|
| Secondary | Change in Qmax From Baseline at Week 4 | All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest. | Posted | Mean | Standard Deviation | mL/sec | 4 weeks |
|
|
|
| Secondary | Categorical Change in Qmax From Baseline at Week 4 | All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest. | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Secondary | Percent Change in Qmax From Baseline at Week 4 | All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest. | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Secondary | Change in Void Volume From Baseline at Week 4 | All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest. | Posted | Mean | Standard Deviation | mL | 4 weeks |
|
|
|
| Secondary | Change in Post-Void Residual Volume From Baseline at Week 4 | All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest. | Posted | Mean | Standard Deviation | mL | 4 weeks |
|
|
|
| Secondary | Change in in Dihydrotestosterone Concentration From Baseline at Week 4 | All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest. | Posted | Mean | Standard Deviation | pg/mL | 4 weeks |
|
|
|
| Secondary | Change in Luteinizing Hormone Concentration From Baseline at Week 4 | All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest. | Posted | Mean | Standard Deviation | IU/L | 4 weeks |
|
|
|
| Secondary | Change in Total Testosterone Concentration From Baseline at Week 4 | All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest. | Posted | Mean | Standard Deviation | nmol/L | 4 weeks |
|
|
|
| Secondary | Participants Assessment of Nocturia at Week 4 | Participants were asked to rate their change in nocturia (number of times you wake from sleep to urinate) since the Baseline Visit. | All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest. | Posted | Median | Full Range | number of times to urinate at night | 4 weeks |
|
|
|
| Secondary | Investigators Assessment of Nocturia at Week 4 | Investigators were asked to rate participant's change in nocturia since the Baseline Visit. | All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest. | Posted | Median | Full Range | number of times urinated at night | 4 weeks |
|
|
|
| Secondary | Change in I-PSS Total Score From Baseline at Week 4 | The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of 6 answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). The first seven questions of the I-PSS are identical to the questions appearing on the American Urological Association (AUA) Symptom Index which currently categorizes symptoms as follows: Mild (symptom score less than of equal to 7); Moderate (symptom score range 8-19); and Severe (symptom score range 20-35). A reduction in I-PSS Total Score is consistent with improvement in symptoms of BPH. | All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
|
|
|
| Secondary | Change in DAN Prostate Symptom Scale From Baseline at Week 4 | The questionnaire is made up of two kinds of questions: intensity of a symptom and bothersomeness of a symptom. Prostate symptoms are addressed in questions 1 - 12 and sexual function in questions 13 - 15. Patients indicate how intense/frequent (scoring 0, 1, 2, or 3; where 0 represents the best case and 3 the worst case) and how bothersome the symptom (scoring 0, 1, 2, or 3; where 0 is 'not at all' and 3 is 'very much'). DAN-PSS total and DAN-PSS total sexual function score were calculated by multiplying the frequency score by the trouble score of each symptom, and then adding the resulting figures. The possible values of DAN-PSS total ranged from 0 to 108 and of DAN-PSS total sexual function score ranged from 0 to 27. A reduction in DAN-PSS total and/or sexual function score is consistent with improved BPH symptoms/sexual functioning. | All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
|
|
|
| 0 |
| 28 |
| 1 |
| 28 |
| 6 |
| 28 |
| EG001 | S-equol 50 mg BID | Experimental: S-equol Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks. At-risk Participants were subjects who received at least one dose of S-at any time during the study. | 0 | 29 | 0 | 29 | 5 | 29 |
| EG002 | S-equol 150 mg BID | Experimental: S-equol Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks. At-risk Participants were subjects who received at least one dose of S-at any time during the study. | 0 | 29 | 1 | 29 | 8 | 29 |
| EG003 | Placebo BID | Placebo Comparator: Placebo Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks. At-risk Participants were subjects who received at least one dose of S-at any time during the study. | 0 | 29 | 0 | 29 | 5 | 29 |
| Electrocardiogram abnormal | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Faeces hard | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastro-oesophageal reflux disease | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Low density lipoprotein increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Prostatic specific antigen increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Micturition disorder | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Urine flow decreased | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Genital rash | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Paraesthesia of genital male | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Prostatomegaly | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Not provided
| D052801 |
| Male Urogenital Diseases |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Change from Baseline |
|
| Change from Baseline |
|
| Week 4 Values, >2 mL/sec |
|
| Week 4 Values, >30% |
|
| Change from Baseline |
|
| Change from Baseline |
|
|
| Change from Baseline |
|
|
|
| Change from Baseline |
|
|
|
| Change from Baseline |
|
|
|
| Change from Baseline |
|
|
|
| Total Score, Change from Baseline |
|
|
| Sexual Function Score, Week 4 Values |
|
|
| Sexual Function Score, Change from Baseline |
|
|