Hormonal Contraception in Healthy Young Men (P42306)(COMPLETED)(P06057)
Phase 2
Completed
- Conditions
- Contraception
- Interventions
- Drug: Placebo
- Registration Number
- NCT00403793
- Lead Sponsor
- Organon and Co
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 350
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 Placebo Placebo Arm 1 etonogestrel with testosterone undecanoate etonogestrel with testosterone undecanoate
- Primary Outcome Measures
Name Time Method % of men who had a sperm concentration of 1 million/ml or less at week 16. Week 16
- Secondary Outcome Measures
Name Time Method Semen Parameters At several timepoints during treatment Reversibility of Suppression Post-Treatment Hormones At several timepoints Pharmacokinetics At several timepoints Safety At several timepoints