A clinical trial to study the safety and efficacy of S-equol in the treatment of Benign Prostate Hyperplasia.
- Conditions
- Health Condition 1: null- Benign Prostatic Hyperplasia
- Registration Number
- CTRI/2012/05/002683
- Lead Sponsor
- Ausio Pharmaceuticals LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 124
Inclusion Criteria
A patient will be eligible for study entry if all of the following inclusion criteria are
met:
1. Is male > 50 and <=70 years of age at Screening.
2. Has a normal digital rectal exam with the exception of prostate enlargement.
3. Has suffered from symptoms of BPH for at least the 6 months before Screening (e.g., micturition disturbances such as daytime frequency, nocturia, urgency, difficulty initiating micturition, impaired quality of the urinary stream, feeling of incomplete voiding, or interruption of the urinary stream).
4. Has a prostate volume >= 20 mL and <= 70 mL as assessed by ultrasound.
5. Has a serum PSA concentration > 1.5 ng/mL and <= 10 ng/mL at Screening.
6. Has an IPSS >= 13 at Screening and Baseline.
7. Has a Qmax > 5 cc/sec and < 15 cc/sec with a voided volume >= 125 cc at Screening (and Baseline, if applicable).
8. Is able to provide written informed consent to participate in the study and able to understand the procedures and study requirements.
9. Must voluntarily sign and date an informed consent form (ICF) that is approved by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) before the conduct of any study procedure.
10. Is willing and able to comply with all study requirements and instructions of the site study staff.
Exclusion Criteria
A patient will not be eligible for study entry if any of the following exclusion criteria are met:
1. Has a known history of allergic reaction or clinically significant intolerance to ingredients of the study drug.
2. Neurogenic bladder dysfunction.
3. Has bladder neck contracture or urethral stricture.
4. Has acute or chronic prostatitis or urinary tract infection.
5. Has, or has a history of, prostate cancer or carcinoma of the prostate suspected on digital rectal exam or transrectal ultrasound, or has a serum PSA concentration > 10 ng/mL; patients with a PSA concentration > 4 ng/mL and <= 10 ng/mL must have prostate cancer ruled out to the satisfaction of the investigator.
6. Has a residual void volume > 250 mL.
7. Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, hepatic, renal, endocrine, or gastric disease or any other condition that, in the opinion of the investigator, could compromise the patientâ??s welfare, ability to communicate with the study staff, or otherwise
contraindicate study participation.
8. Shows presence of any manifest premalignant or malignant disease except treated skin cancers (except melanoma).
9. Has a history of smoking more than 5 cigarettes daily within the year before
Screening.
10. Has resting systolic blood pressure (BP) > 160 mmHg or < 90 mmHg, or diastolic
BP > 90 mmHg or < 60 mmHg at Screening.
11. Has bladder stones as detected by ultrasound.
12. Has hematuria of unknown etiology.
13. Had previous prostate surgery or other invasive treatment for BPH.
14. Had prior radiation to the pelvis.
15. Has Parkinsonâ??s disease or multiple sclerosis.
16. Had stroke or myocardial infarction within 5 months before Baseline.
17. Has clinically significant abnormal screening electrocardiogram (ECG) or unstable
angina or severe congestive heart failure.
18. Has active liver disease with aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN), alanine aminotransferase (ALT) > 2 times ULN, unexplained alkaline phosphatase > 3 times ULN, total bilirubin > ULN, renal insufficiency with creatinine > 1.7 mg/dL, or clinically significant abnormal hemoglobin, white blood cell count, or platelet count.
19. Has a history of postural hypotension or has a fall in systolic BP > 20 mm Hg after 2 minutes in a standing position.
20. Received alpha blocker therapy within 28 days before Baseline.
21. Received androgens, anti-androgens, 5-alpha reductase inhibitors, or luteinizing hormone-releasing hormone (LHRH) analogs within 3 months before Baseline.
22. Received tricyclic antidepressants or plant extracts (e.g., saw palmetto) within 1 month before Baseline.
23. Received sedating antihistamines, sympathomimetics, or anticholinergics within 1 week before Baseline.
24. Has initiated new use (i.e., within the past 4 weeks before Screening) or otherwise are not on stable doses of phosphodiesterase-5 inhibitors during the 4 weeks before Screening.
25. Has known or suspected history of alcoholism or drug abuse or misuse within the last 5 years.
26. Is considered by the investigator, for any reason (including, but not limited to, the risks described as precautions, warnings, and contraindications in the current versi
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy endpoint is the change from Baseline in PSA concentration at the Week 4 <br/ ><br>Visit (V5).Timepoint: Day 28 ±2 days
- Secondary Outcome Measures
Name Time Method The secondary endpoints are the following: â?¢ Change from Baseline in prostate size (assessed by transrectal ultrasonography) <br/ ><br>â?¢ Change from Baseline in Qmax <br/ ><br>â?¢ Percent of patients with change from Baseline in Qmax 2 cc/sec <br/ ><br>â?¢ Percent of patients with change from Baseline in Qmax 30% â?¢ Change from Baseline in PSA concentration <br/ ><br>â?¢ Change from Baseline in PSA densityTimepoint: Change from Baseline in prostate size <br/ ><br>Change from Baseline in Qmax