• The effect of Org 3236 on prostate volume compared to placebo [ Time Frame: Screening (days -30 to -1), weeks 8, 12 and 24 ] [ Designated as safety issue: No ]
• The effect of Org 3236 on LUTS compared to placebo [ Time Frame: Screening up to and including week 24 ] [ Designated as safety issue: No ]
• The effect of Org 3236 on urinary flow and postvoid residual volume compared to placebo [ Time Frame: Screening and weeks 2 - 24 ] [ Designated as safety issue: No ]
• The effect on progression of LUTS [ Time Frame: Screening up to and including week 24 ] [ Designated as safety issue: No ]
• The effect of Org 3236 on sexual function; well-being and LUTS-related Quality of Life compared to placebo [ Time Frame: Screening and weeks 4 - 24; screening and weeks 2 - 24, respectively ] [ Designated as safety issue: No ]
• The safety of Org 3236 [ Time Frame: Screening up to and including week 24 ] [ Designated as safety issue: Yes ]
• The pharmacokinetic (Org 3236) and pharmacodynamic (T, DHT, LH, FSH, E2, SHBG) properties [ Time Frame: Randomization and weeks 2 - 8; randomization and weeks 2 - 12 and 24, respectively ] [ Designated as safety issue: No ]

• The effect of Org 3236 on prostate volume compared to placebo; [ Time Frame: Screening (days -30 to -1), weeks 8, 12 and 24 ] [ Designated as safety issue: No ]
• The effect of Org 3236 on LUTS compared to placebo; [ Time Frame: Screening up to and including week 24 ] [ Designated as safety issue: No ]
• The effect of Org 3236 on urinary flow and postvoid residual volume compared to placebo; [ Time Frame: Screening and weeks 2 - 24 ] [ Designated as safety issue: No ]
• The effect on progression of LUTS; [ Time Frame: Screening up to and including week 24 ] [ Designated as safety issue: No ]
• The effect of Org 3236 on sexual function; well-being and LUTS-related Quality of Life compared to placebo; [ Time Frame: Screening and weeks 4 - 24; screening and weeks 2 - 24, respectively ] [ Designated as safety issue: No ]
• The safety of Org 3236; [ Time Frame: Screening up to and including week 24 ] [ Designated as safety issue: Yes ]
• The pharmacokinetic (Org 3236) and pharmacodynamic (T, DHT, LH, FSH, E2, SHBG) properties. [ Time Frame: Randomization and weeks 2 - 8; randomization and weeks 2 - 12 and 24, respectively ] [ Designated as safety issue: No ]

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.

• Drug: etonogestrel
• Drug: Placebo

• Active Comparator: etonogestrel
• Placebo Comparator: Placebo

• 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.
• 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. Review. No abstract available.

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