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)

This study has been terminated.
(Business Reasons)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00651807
First received: March 31, 2008
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Benign Prostatic Hyperplasia (BPH)
Drug: etonogestrel
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • The effect of Org 3236 on prostate volume compared to placebo [ Time Frame: Screening (days -30 to -1), weeks 8, 12 and 24 ] [ Designated as safety issue: No ]
  • The effect of Org 3236 on LUTS compared to placebo [ Time Frame: Screening up to and including week 24 ] [ Designated as safety issue: No ]
  • The effect of Org 3236 on urinary flow and postvoid residual volume compared to placebo [ Time Frame: Screening and weeks 2 - 24 ] [ Designated as safety issue: No ]
  • The effect on progression of LUTS [ Time Frame: Screening up to and including week 24 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The safety of Org 3236 [ Time Frame: Screening up to and including week 24 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: March 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Org 3236
Placebo Comparator: Arm 2
Placebo
Drug: Placebo
Every day one tablet up to 8 weeks

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00651807     History of Changes
Other Study ID Numbers: P05806, 304001
Study First Received: March 31, 2008
Last Updated: February 6, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Lower Urinary Tract Symptoms
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Urological Manifestations
Signs and Symptoms
3-keto-desogestrel
Desogestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 20, 2014