Hormonal Contraception in Healthy Young Men (P42306)(COMPLETED)(P06057) (NCT00403793) | Clinical Trial Compass
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 range
18 Years – 45 Years
Sex
MALE
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
% of men who had a sperm concentration of 1 million/ml or less at week 16.