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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00403793
First Posted: November 27, 2006
Last Update Posted: July 14, 2015
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.
Collaborator:
Bayer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Semen Parameters [ Time Frame: At several timepoints during treatment ]
  • Reversibility of Suppression [ Time Frame: Post-Treatment ]
  • Hormones [ Time Frame: At several timepoints ]
  • Pharmacokinetics [ Time Frame: At several timepoints ]
  • Safety [ Time Frame: At several timepoints ]

Enrollment: 350
Study Start Date: October 2003
Study Completion Date: December 2006
Primary Completion Date: December 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
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: P06057
First Submitted: November 22, 2006
First Posted: November 27, 2006
Last Update Posted: July 14, 2015
Last Verified: July 2015

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