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

NCT00403793 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2022-02-04

No results posted yet for this study

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.

Conditions

  • Contraception

Interventions

DRUG

etonogestrel with testosterone undecanoate

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

DRUG

Placebo

42 or 44 weeks with placebo implant and placebo injections

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2006-12-31
Completion
2006-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00403793 on ClinicalTrials.gov