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)

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