Hormonal Contraception in Healthy Young Men (P42306)(COMPLETED)(P06057)

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2006-12-31

Brief Summary

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Male volunteers receive a new hormonal contraceptive consisting of an implant releasing a hormone and hormone injections in order to investigate the suppressive effect on sperm production and reversibility of sperm production after end of treatment.

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Detailed Description

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Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

etonogestrel with testosterone undecanoate

Group Type ACTIVE_COMPARATOR

etonogestrel with testosterone undecanoate

Intervention Type DRUG

42 or 44 weeks with etonogestrel implant and testosterone undecanoate injections every 10 to 12 weeks

Arm 2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

42 or 44 weeks with placebo implant and placebo injections

Interventions

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etonogestrel with testosterone undecanoate

42 or 44 weeks with etonogestrel implant and testosterone undecanoate injections every 10 to 12 weeks

Intervention Type DRUG

Placebo

42 or 44 weeks with placebo implant and placebo injections

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male
* Mentally and physically healthy
* BMI between 18 and 32 kg/m\^2
* Two pre-treatment semen samples \> 20 million/ml with normal morphology and motility

Exclusion Criteria

* History or presence of psychiatric disease, liver disease, renal disease, diabetes, cardiovascular disease, any malignancy, prostatic disease, or genitourinary infection
* PSA \> 2.5 ng/ml
* Use of drugs known to interfere with pharmacokinetics of steroids
* Use of lipid-lowering drugs

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes