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)

Study Overview
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Brief Summary
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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.

Official Title
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Phase II, Randomized, Double-Blind, Placebo-Controlled Trial Investigating the Efficacy and Safety of Org 3236 Tablets in Men With Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia (BPH)

Conditions
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Benign Prostatic Hyperplasia (BPH)

Intervention / Treatment
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* Drug: etonogestrel
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>etonogestrel | Drug: etonogestrel<br>* Lowest dose of Org 3236 per two days, lowest dose of Org 3236 per day, highest dose of Org 3236 per day for 8 weeks<br>* Other names: Org 3236;|
| Placebo Comparator: Arm 2<br>Placebo | Drug: Placebo<br>* Every day one tablet up to 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of Org 3236 on prostate volume compared to placebo |  | Screening (days -30 to -1), weeks 8, 12 and 24 | 
| The effect of Org 3236 on LUTS compared to placebo |  | Screening up to and including week 24 | 
| The effect of Org 3236 on urinary flow and postvoid residual volume compared to placebo |  | Screening and weeks 2 - 24 | 
| The effect on progression of LUTS |  | Screening up to and including week 24 | 
| The effect of Org 3236 on sexual function; well-being and LUTS-related Quality of Life compared to placebo |  | Screening and weeks 4 - 24; screening and weeks 2 - 24, respectively | 
| The safety of Org 3236 |  | Screening up to and including week 24 | 
| The pharmacokinetic (Org 3236) and pharmacodynamic (T, DHT, LH, FSH, E2, SHBG) properties |  | Randomization and weeks 2 - 8; randomization and weeks 2 - 12 and 24, respectively |