Status:
COMPLETED
Hormonal Contraception in Healthy Young Men (P42306)(COMPLETED)(P06057)
Lead Sponsor:
Organon and Co
Collaborating Sponsors:
Bayer
Conditions:
Contraception
Eligibility:
MALE
18-45 years
Phase:
PHASE2
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 reversib...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00403793
Start Date
October 1 2003
End Date
December 1 2006
Last Update
February 4 2022
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