This clinical trial tests several products for their future usefulness for male contraception.
Conditions
Interventions
Trade Name: Androcur-10
Product Name: cyproterone acetate
Product Code: CPA
Pharmaceutical Form: Tablet
INN or Proposed INN: cyproterone acetate
CAS Number: 0000427-51-0
Concentration unit: mg millig
Sponsors
Population Council - Center for Biomedical Research
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Percent change of gonadotropin suppression (see section 16.2 of the study protocol). ;Main Objective: This a dose-finding study to assess the antigonadotropic doses of progestins when administered to men. The primary objective is to determine the ability of various progestins administered alone at two different doses during the 2 weeks to suppress two gonadotrophins: follicle stimulating hormone (FSH) and luteinizing hormone (LH). The same progestins given at the same 2 doses will then be administered in combination with transdermal testosterone gel for 4 weeks in order to maintain or increase the suppression of gonadotrophins while providing normal androgenic function in men. Serum levels of FSH and LH will be assessed during treatment with progestins alone and after combined treatment with progestins and transdermal testosterone.;Secondary Objective: The secondary objectives are to determine the effects of treatment on: - serum level of testosterone, estradiol and Sex hormone-binding globulin (SHBG) - safety of treatment: CBC, clinical chemistry, lipids, inflammation markers and semen analysis - changes in subject behavior will be monitored during the study using the questionnaire "Evaluation of Subject Behavior" | — |
Countries
Germany
Outcome results
None listed