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)

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.

Timeline

Start

2008-03

Primary completion

2008-08

Completion

2008-08

Publications

• Background Madersbacher S, Alivizatos G, Nordling J, Sanz CR, Emberton M, de la Rosette JJ. EAU 2004 guidelines on assessment, therapy and follow-up of men with lower urinary tract symptoms suggestive of benign prostatic obstruction (BPH guidelines). Eur Urol. 2004 Nov;46(5):547-54. doi: 10.1016/j.eururo.2004.07.016.
• Background Gonzalez CM, McVary KT. The role of combination therapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia. Curr Urol Rep. 2003 Aug;4(4):276-81. doi: 10.1007/s11934-003-0084-1. No abstract available.
• Background McConnell J, Abrams P, Denis L, Khoury S, Roehrborn C (eds). Male Lower Urinary Tract Dysfunction - Evaluation and Management. Edition 2006 Paris, France: Editions 21, ISBN 0-9546956-6-6.

Drugs

Indications