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NCT00167141 Clinical Trial

Contraception in Normal and Subnormal Men

Healthy Clinical Trial

Official title:
Hormonal Male Contraception in Men With Normal and Subnormal Semen Parameters

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00167141
Other study ID # IRM 2003/21
Secondary ID IRM 2003/21
Status Terminated
Phase Phase 2
First received September 6, 2005
Last updated February 1, 2010
Start date February 2005
Est. completion date January 2008

Study information
Verified date March 2007
Source University Hospital Muenster
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 41
Est. completion date January 2008
Est. primary completion date December 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria:

- Volunteers with normal and subnormal semen parameters

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• injection of hormonal male contraceptive
testosterone injections 4 times

Locations
Country Name City State
Germany Prof. Dr. Eberhard Nieschlag Muenster

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary semen parameters 2005 - 2008 Yes
Secondary hormones 2005 2008 Yes
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