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OpenTrials
Completed

NCT Number: NCT00403793

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

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.

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Key information

Conditions

Contraception

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

etonogestrel with testosterone undecanoate

Drug

42 or 44 weeks with etonogestrel implant and testosterone undecanoate injections every 10 to 12 weeks

Placebo

Drug

42 or 44 weeks with placebo implant and placebo injections

Primary outcomes

  1. % of men who had a sperm concentration of 1 million/ml or less at week 16.

    Time frame: Week 16

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Collaborators

  • Bayer

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Nov 27, 2006
Registry last updated
Feb 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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