NCT00651807

A Trial to Investigate the Effectiveness and Safety of Org 3236 (Etonogestrel) Tablets in Men With Urinary Complaints Suggestive of a Benign Enlargement of the Prostate (304001)(P05806)

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Male
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted to evaluate the effect of etonogestrel in comparison to placebo on: * the prostate volume and the urinary complaints; * the urinary flow and the urinary volume in the bladder after voiding; * the progression of the disease; * the sexual function, well-being and urinary complaints-related Quality of Life. In addition the safety and the way the drug is absorbed and excreted by the body will be analyzed.

Conditions

• Benign Prostatic Hyperplasia (BPH)

Interventions

Type	Name	Description
DRUG	etonogestrel	Lowest dose of Org 3236 per two days, lowest dose of Org 3236 per day, highest dose of Org 3236 per day for 8 weeks
DRUG	Placebo	Every day one tablet up to 8 weeks

Timeline

• Start date: 2008-03-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2008-04-03
• Last updated: 2026-04-08

Locations

1 site across 1 country: Argentina