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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00651807
Recruitment Status : Terminated (Business Reasons)
First Posted : April 3, 2008
Last Update Posted : February 4, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia (BPH) Drug: etonogestrel Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : March 2008
Primary Completion Date : August 2008
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Arm 1
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 Name: Org 3236
Placebo Comparator: Arm 2
Drug: Placebo
Every day one tablet up to 8 weeks

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

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00651807     History of Changes
Other Study ID Numbers: P05806
First Posted: April 3, 2008    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urological Manifestations
Signs and Symptoms
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists