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)

NCT00651807 | Terminated Phase 2

• 2 other identifiers: P05806304001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia (BPH)

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

etonogestrel

Drug: etonogestrel

Arm 2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Placebo DRUG

Every day one tablet up to 8 weeks

Arm 2

etonogestrel DRUG

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

Also known as: Org 3236

Arm 1

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Study Sites (1)

Instituto Médico Especializado

Buenos Aires, Hidalgo, 1405, Argentina

Location

Related Publications (3)

• 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.

  PMID: 15474261 BACKGROUND

• 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.

  PMID: 12882718 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

etonogestrel

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 3, 2008
• Study Start: March 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: April 8, 2026

Record last verified: 2022-02

Locations

AR (1)