Contraception in Normal and Subnormal Men

NCT ID: NCT00167141

Last Updated: 2010-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2008-01-31

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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testosterone injections

injections of testosterone to normal men (arm 1) and two men with subnormal semen parameters (arm 2)

Group Type EXPERIMENTAL

injection of hormonal male contraceptive

Intervention Type DRUG

testosterone injections 4 times

Interventions

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injection of hormonal male contraceptive

testosterone injections 4 times

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Volunteers with normal and subnormal semen parameters
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Muenster

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Muenster

Principal Investigators

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Eberhard Nieschlag, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Institute of Reproductive Medicine

Locations

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Prof. Dr. Eberhard Nieschlag

Münster, , Germany

Site Status

Countries

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Germany

Other Identifiers

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IRM 2003/21

Identifier Type: -

Identifier Source: secondary_id

IRM 2003/21

Identifier Type: -

Identifier Source: org_study_id

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