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 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)

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.

Study Overview

• Status: Terminated
• Conditions: Benign Prostatic Hyperplasia (BPH)
• Intervention / Treatment: Drug: etonogestrel; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Arm 2; Placebo	Drug: Placebo; Every day one tablet up to 8 weeks
Active Comparator: Arm 1; etonogestrel	Drug: etonogestrel; 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; Other Names: Org 3236

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• 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. doi: 10.1016/j.eururo.2004.07.016.
• 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. doi: 10.1007/s11934-003-0084-1. No abstract available.
• McConnell J, Abrams P, Denis L, Khoury S, Roehrborn C (eds). Male Lower Urinary Tract Dysfunction - Evaluation and Management. Edition 2006 Paris, France: Editions 21, ISBN 0-9546956-6-6.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: March 31, 2008
• First Submitted That Met QC Criteria: March 31, 2008
• First Posted (Estimate): April 3, 2008

Study Record Updates

• Last Update Posted (Actual): February 4, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Etonogestrel
• Other Study ID Numbers: P05806; 304001