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

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: NCT00403793
Recruitment Status : Completed
First Posted : November 27, 2006
Last Update Posted : July 14, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Contraception Drug: etonogestrel with testosterone undecanoate Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
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
Study Start Date : October 2003
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Arm Intervention/treatment
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
Drug: Placebo
42 or 44 weeks with placebo implant and placebo injections

Primary Outcome Measures :
  1. % of men who had a sperm concentration of 1 million/ml or less at week 16. [ Time Frame: Week 16 ]

Secondary Outcome Measures :
  1. Semen Parameters [ Time Frame: At several timepoints during treatment ]
  2. Reversibility of Suppression [ Time Frame: Post-Treatment ]
  3. Hormones [ Time Frame: At several timepoints ]
  4. Pharmacokinetics [ Time Frame: At several timepoints ]
  5. Safety [ Time Frame: At several timepoints ]

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

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
Publications of Results:
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00403793    
Other Study ID Numbers: P06057
First Posted: November 27, 2006    Key Record Dates
Last Update Posted: July 14, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
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