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

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ClinicalTrials.gov Identifier: NCT00403793
Recruitment Status : Completed
First Posted : November 27, 2006
Last Update Posted : July 14, 2015
Sponsor:
Collaborator:
Bayer
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

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
Placebo
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 ]


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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

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00403793     History of Changes
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:
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