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

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: Bayer
• Treatments: Desogestrel; Etonogestrel; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

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