Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT00603304
Eligibility Criteria:
Inclusion Criteria:
To be eligible for the study, potential participants must meet all of the following eligibility criteria:
1. Male at least 45 years of age.
2. Peak urinary flow rate at least 4 ml/sec with a voided volume of at least 125 ml.
3. AUA symptom score ≥ 8 and ≤ 24 at both screening visits.
4. Voluntarily signed informed consent agreement prior to the performance of any study procedures.
Exclusion Criteria:
Potential participants that meet any of the following exclusion criteria will be excluded from the full-scale trial:
1. Any prior invasive intervention for BPH.
2. Phytotherapy for BPH or a 5-alpha reductase inhibitor within 3 months.
3. Alpha blocker within one month.
4. Reported allergic reaction to Serenoa repens.
5. Taken phenylephrine, pseudoephedrine, tricyclic antidepressants, and anticholinergic or cholinergic medication within 4 weeks of the first screening visit, with the following exception: topical anticholinergic eye drops used for glaucoma.
6. Taken an estrogen, androgen, or any drug producing androgen suppression, or anabolic steroids within 6 months.
7. Known clinically significant renal impairment (i.e., creatinine greater than 2.0 mg/dl).
8. Alanine aminotransferase(ALT)serum glutamic pyruvic transaminase(SGPT), aspartate aminotransferase(AST)serum glutamic oxaloacetic transaminase (SGOT) or gamma-glutamyltranspeptidase (GGT) value greater than 3 times the upper limit of normal in the clinical center lab at SV1.0; confirmed on a second measurement.
9. Prothrombin time greater than 3 seconds above the upper limit of normal, or more than 3 seconds above the control value in the clinical center at SV1.0; confirmed on a second measurement.
10. Electrocardiogram (ECG) reading at the clinical center at SV1.0 suggesting active ischemia or recent myocardial infarction until appropriate consultation confirms the absence of an acute coronary syndrome.
11. Prostate-specific antigen (PSA) level greater than 10 ng/ml at the first screening visit.
12. Requires the daily use of a pad or device for incontinence, or International Continence Society male incontinence symptom (ICSmaleIS) score \>14 at screening.
13. Unstable medical condition within the past 3 months.
14. History or current evidence of carcinoma of the prostate or bladder, pelvic radiation or surgery, urethral stricture, or prior surgery for bladder neck obstruction.
15. Active urinary tract disease or has undergone cystoscopy or biopsy of the prostate within one month prior to the first screening visit or has an imminent need for urologic surgery.
16. Known primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function.
17. Documented bacterial prostatitis within the past year.
18. Two documented independent urinary tract infections of any type in the past year.
19. Known severe bleeding disorder or need for ongoing therapeutic anticoagulation with coumadin or heparin.
20. Cancer, which is not considered cured (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered cured if there has been no evidence of cancer within five years of randomization. A history of bladder cancer or prostate cancer is exclusionary whether the participant is considered cured or not.
21. Unable to follow protocol directions due to organic brain or psychiatric disease.
22. History of alcoholism or any other substance abuse, which, in the opinion of the investigator, would affect compliance with the protocol.
23. Any serious medical condition likely to impede successful completion of the study.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
45 Years
Study:
NCT00603304
Study Brief:
Protocol Section:
NCT00603304