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Contraception in Normal and Subnormal Men

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ClinicalTrials.gov Identifier: NCT00167141
Recruitment Status : Terminated
First Posted : September 14, 2005
Last Update Posted : February 2, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: injection of hormonal male contraceptive Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hormonal Male Contraception in Men With Normal and Subnormal Semen Parameters
Study Start Date : February 2005
Primary Completion Date : December 2007
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. semen parameters [ Time Frame: 2005 - 2008 ]

Secondary Outcome Measures :
  1. hormones [ Time Frame: 2005 2008 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Volunteers with normal and subnormal semen parameters

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Prof. Dr. Eberhard Nieschlag, University Hospital Muenster
ClinicalTrials.gov Identifier: NCT00167141     History of Changes
Other Study ID Numbers: IRM 2003/21
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: February 2, 2010
Last Verified: March 2007

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
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Reproductive Control Agents