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Contraception in Normal and Subnormal Men

This study has been terminated.
Sponsor:
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00167141
First received: September 6, 2005
Last updated: February 1, 2010
Last verified: March 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: injection of hormonal male contraceptive
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hormonal Male Contraception in Men With Normal and Subnormal Semen Parameters

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • semen parameters [ Time Frame: 2005 - 2008 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • hormones [ Time Frame: 2005 2008 ] [ Designated as safety issue: Yes ]

Enrollment: 41
Study Start Date: February 2005
Study Completion Date: January 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: testosterone injections
injections of testosterone to normal men (arm 1) and two men with subnormal semen parameters (arm 2)
 Drug: injection of hormonal male contraceptive
testosterone injections 4 times

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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Volunteers with normal and subnormal semen parameters
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00167141

Locations
Germany
Prof. Dr. Eberhard Nieschlag
Muenster, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
Investigators
Principal Investigator: Eberhard Nieschlag, Prof. Dr. Institute of Reproductive Medicine
  More Information

No publications provided

Responsible Party: Prof. Dr. Eberhard Nieschlag, University Hospital Muenster
ClinicalTrials.gov Identifier: NCT00167141     History of Changes
Other Study ID Numbers: IRM 2003/21, IRM 2003/21
Study First Received: September 6, 2005
Last Updated: February 1, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Muenster:
male fertility
semen parameters

Additional relevant MeSH terms:
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Contraceptive Agents
Contraceptive Agents, Male
Androgens
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 22, 2013