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

Phase 2

Completed

• Conditions: Contraception
• Interventions: Drug: Placebo; Drug: etonogestrel with testosterone undecanoate

• Registration Number: NCT00403793
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2006-11-22
• Study First Submitted QC: 2006-11-24
• Study First Posted: 2006-11-27
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-02
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Placebo	Placebo
Arm 1	etonogestrel with testosterone undecanoate	etonogestrel with testosterone undecanoate

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Semen Parameters	At several timepoints during treatment
Reversibility of Suppression	Post-Treatment
Hormones	At several timepoints
Pharmacokinetics	At several timepoints
Safety	At several timepoints