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

A Phase II -b, Placebo-Controlled Trial Investigating the Efficacy, Safety and Pharmacokinetics of a Subcutaneous Etonogestrel Implant Combined With i.m. Testosterone Undecanoate for Male Contraception

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.

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