Hormonal Contraception in Healthy Young Men (P42306)(COMPLETED)(P06057)

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00403793
First received: November 22, 2006
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

Male volunteers receive a new hormonal contraceptive consisting of an implant releasing a hormone and hormone injections in order to investigate the suppressive effect on sperm production and reversibility of sperm production after end of treatment.


Condition Intervention Phase
Contraception
Drug: etonogestrel with testosterone undecanoate
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: Prevention
Official Title: A Phase II -b, Placebo-Controlled Trial Investigating the Efficacy, Safety and Pharmacokinetics of a Subcutaneous Etonogestrel Implant Combined With i.m. Testosterone Undecanoate for Male Contraception

Resource links provided by NLM:


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

Primary Outcome Measures:
  • % of men who had a sperm concentration of 1 million/ml or less at week 16. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Semen Parameters [ Time Frame: At several timepoints during treatment ] [ Designated as safety issue: No ]
  • Reversibility of Suppression [ Time Frame: Post-Treatment ] [ Designated as safety issue: Yes ]
  • Hormones [ Time Frame: At several timepoints ] [ Designated as safety issue: No ]
  • Pharmacokinetics [ Time Frame: At several timepoints ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: At several timepoints ] [ Designated as safety issue: Yes ]

Enrollment: 350
Study Start Date: December 2003
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
etonogestrel with testosterone undecanoate
Drug: etonogestrel with testosterone undecanoate
42 or 44 weeks with etonogestrel implant and testosterone undecanoate injections every 10 to 12 weeks
Placebo Comparator: Arm 2
Placebo
Drug: Placebo
42 or 44 weeks with placebo implant and placebo injections

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male
  • Mentally and physically healthy
  • BMI between 18 and 32 kg/m^2
  • Two pre-treatment semen samples > 20 million/ml with normal morphology and motility

Exclusion Criteria:

  • History or presence of psychiatric disease, liver disease, renal disease, diabetes, cardiovascular disease, any malignancy, prostatic disease, or genitourinary infection
  • PSA > 2.5 ng/ml
  • Use of drugs known to interfere with pharmacokinetics of steroids
  • Use of lipid-lowering drugs
  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: NCT00403793     History of Changes
Other Study ID Numbers: P42306
Study First Received: November 22, 2006
Last Updated: March 21, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Italy: The Italian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Desogestrel
3-keto-desogestrel
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Progestins

ClinicalTrials.gov processed this record on August 25, 2014