A 20-Week Study of a New Treatment for Men With Benign Prostatic Hyperplasia (BPH).

• Status: Unknown status
• Trial end date: 2002-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

Patients who are currently symptomatic and have been diagnosed with BPH by a physician may qualify for this 20-week study. Patients must not be diabetic, must not have prostate cancer and must not have had any surgery to repair your prostate or treat your BPH. Patients will first undergo a phone screening to confirm their eligibility and interest and to rule out any exclusionary history or medications. Eligible patients will be scheduled to come in to the clinic to sign an Informed Consent Form. Patients will then undergo blood and urine tests, a complete physical examination and history and answer several questionnaires to determine their eligibility. Patients will have a total of at least 7-8 visits over 20 weeks to the clinic during this study.Qualified patients receive free study medication, free medical care (physical examinations, EKG, laboratory tests) for the duration of the study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Milkhaus Laboratory

Criteria

• Have an enlarged prostate by DRE (digital rectal examination);

• Have a diagnosis of BPH;

• Have documented symptoms (frequency; urgency; nighttime urination; reduced flow);

• Have a documented urinary flow rate as required