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)
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)
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.
Inclusion Criteria:

 -  Signed written informed consent, obtained before screening evaluations;

 -  Men diagnosed with LUTS suggestive of BPH: Baseline IPSS score of = 12 (moderate to
 severe); Prostate volume of = 40 mL and < 100 mL (based on TRUS); Peak urinary flow
 rate = 15 mL/s with a voided volume of =125 mL

 -  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 (e.g. by biopsy)

 Exclusion Criteria:

 -  A post void residual volume >250 mL

 -  Use of drugs interfering with efficacy assessments within two weeks or six months
 prior to start treatment (depending on drug)

 -  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

 -  Cardiac or cerebrovascular event within the past six months

 -  Presence or history of any neurological disease associated with primary bladder
 dysfunction

 -  Presence or history of liver/renal disease or disturbance of liver/renal function that
 failed to return to normal

 -  Clinically relevant abnormal laboratory result as judged by the (sub)investigator