Clinical Trials Directory

Trials / Completed

CompletedNCT00403793

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

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
350 (actual)
Sponsor
Organon and Co · Industry
Sex
Male
Age
18 Years – 45 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DRUGetonogestrel with testosterone undecanoate42 or 44 weeks with etonogestrel implant and testosterone undecanoate injections every 10 to 12 weeks
DRUGPlacebo42 or 44 weeks with placebo implant and placebo injections

Timeline

Start date
2003-10-01
Primary completion
2006-12-01
Completion
2006-12-01
First posted
2006-11-27
Last updated
2022-02-04

Source: ClinicalTrials.gov record NCT00403793. Inclusion in this directory is not an endorsement.