Business Reasons

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