Contraception in Normal and Subnormal Men

Phase 2

Terminated

• Conditions: Healthy
• Interventions: Drug: injection of hormonal male contraceptive

• Registration Number: NCT00167141
• Lead Sponsor: University Hospital Muenster

Brief Summary

Volunteers with normal and subnormal semen parameters receive a hormonal male contraceptive in order to investigate whether there are differences between normal and subnormal men in terms of suppressibility, rate of azoospermia and reversibility of suppression of spermatogenesis.

Detailed Description

Volunteers with normal and subnormal semen parameters receive a hormonal male contraceptive in order to investigate whether there are differences between normal and subnormal men in terms of suppressibility, rate of azoospermia and reversibility of suppression of spermatogenesis. Twenty-five men will be recruited for each group. They will be exposed to hormonal male contraception for six months.

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-14
• Status Verified: 2007-03
• Primary Completion: 2007-12
• Study Completion: 2008-01
• Last Update Submitted: 2010-02-01
• Last Update Posted: 2010-02-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 41

Inclusion Criteria

• Volunteers with normal and subnormal semen parameters

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
testosterone injections	injection of hormonal male contraceptive	injections of testosterone to normal men (arm 1) and two men with subnormal semen parameters (arm 2)

Primary Outcome Measures

Name	Time	Method
semen parameters	2005 - 2008

Secondary Outcome Measures

Name	Time	Method
hormones	2005 2008

Trial Locations

Locations (1)

Prof. Dr. Eberhard Nieschlag; 🇩🇪 Muenster, Germany