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)

Phase 2

Terminated

• Conditions: Benign Prostatic Hyperplasia (BPH)
• Interventions: Drug: etonogestrel; Drug: Placebo

• Registration Number: NCT00651807
• Lead Sponsor: Organon and Co

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-31
• Study First Submitted QC: 2008-03-31
• Study First Posted: 2008-04-03
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-02
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	etonogestrel	etonogestrel
Arm 2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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
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