A dose-finding randomized clinical trial to evaluate the differential impact of four progestins for their use as male contraceptives in healthy men.

• Conditions: This clinical trial tests several products for their future usefulness for male contraception.

• Registration Number: EUCTR2005-002409-21-DE
• Lead Sponsor: Population Council - Center for Biomedical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Men who meet all the following criteria are eligible for enrolment in the trial:
1. Caucasian male volunteers in good health
2. 18 to 50 years of age
3. BMI= 33
4. Not using hormonal therapy in the last six months
5. Subject or his partner is willing to use a recognized effective method of contraception
6. In the opinion of the investigator, is able to comply with the protocol, understand and sign an informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Men who meet all the following criteria are not eligible for enrolment in the trial:
1. Asian
2. Men participating in another clinical trial
3. Men not living in the catchment area of the clinic
4. Clinically significant abnormal findings at screening
5. Elevated prostate specific antigen (PSA), according to local laboratory normal values
6. Abnormal serum chemistry values according to local laboratory normal values, which indicate liver or kidney dysfunction. Other abnormal lab values may also be exclusionary, at the discretion of the investigator. The investigator will use the following criteria for exclusion:
- liver function test abnormalities of greater than 1.5 times the upper limit of normal
- abormal prolactin level (1.5 times the upper limit of normal)
7. History of sleep apnea and/or psychiatric problems
8. History of hepatitis A, B or C
9. Using androgens or body building substances
10. Diastolic blood pressure (BP) = 90 and systolic BP= 140 mmHg
11. History of hypertension, including hypertension controlled with treatment
12. Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis
13. Known history of prostatic diseases or disorders
14. Known family history of prostate cancer
15. Known hypersensitivity to progestins
16. Contraindications to the progestins as per package insert
17. History of venous thromboembolism
18. Benign or malignant liver tumors; active liver disease
19. Known history of reproductive dysfunction including vasectomy or infertility
20. Known or suspected alcoholism or drug abuse
21. Excessive alcohol consumption, according to the investigator's judgement
22. Known dermatitis or severe skin disorder
The following termination criteria will be used to exclude the subjects at any time before or during the study:
- hemoglobin levels above 18.0 g/L
- confirmed elevations of AST, ALT, or alkaline phosphatase above three times upper normal.
Men desiring fertility within 6 months or participating in competitive sports where drug screening for prohibited substances (including anabolic steroids) is routine will be advised of the relative and temporary hazards that participating in this study may have for their fertility or sporting status.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified