CompletedPhase 2

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

350 participantsStarted 2003-10

Plain-language summary

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.

Who can participate

Age range18 Years – 45 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

% of men who had a sperm concentration of 1 million/ml or less at week 16.

Timeframe: Week 16

Trial details

NCT IDNCT00403793

SponsorOrganon and Co

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-12

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