Contraception
Conditions
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.
Interventions
DRUGetonogestrel with testosterone undecanoate
42 or 44 weeks with etonogestrel implant and testosterone undecanoate injections every 10 to 12 weeks
DRUGPlacebo
42 or 44 weeks with placebo implant and placebo injections
Sponsors
Bayer
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| % of men who had a sperm concentration of 1 million/ml or less at week 16. | Week 16 |
Secondary
| Measure | Time frame |
|---|---|
| Semen Parameters | At several timepoints during treatment |
| Reversibility of Suppression | Post-Treatment |
| Hormones | At several timepoints |
| Pharmacokinetics | At several timepoints |
| Safety | At several timepoints |
Outcome results
None listed