A phase II, randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of Org 3236 tablets in men with Lower Urinary Tract Symptoms (LUTS) suggestive of Benign Prostatic Hyperplasia (BPH)
- Conditions
- prostate hyperplasia10046590
- Registration Number
- NL-OMON31439
- Lead Sponsor
- Organon Nederland BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 36
- Men diagnosed with LUTS suggestive of BPH
- Age at least 50 but not older than 80 years at screening
- PSA < 10 ng/mL and exclusion of prostate cancer to the satisfaction of the investigator
- A postvoid residual volume >250 mL
- Use of anti-androgens, androgens, Gonadotropin Releasing Hormone (GnRH) antagonists, or 5alfa-reducatase inhibitors within six months prior to start trial medication
- Presence of hypogonadism as judged by the investigator
- Acute urinary retention within the past 12 months
- History of surgery for BPH, including other minimally invasive procedures
- Presence of urinary tract infection
- Presence or history of (subclinical ) prostate cancer, bladder cancer, urethral stricture, or pelvic irradiation
- Presence or history of any neurological disease associated with primary bladder dysfunction.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method