Study of the Safety, and Sperm and Gonadotropin Suppression of a Contraceptive Gel in Normal Men

Exclusion Criteria

• •1. Men participating in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit
• •2. Men not living in the catchment's area of the clinic or within a reasonable distance from the site
• •3. Clinically significant abnormal findings at screening
• •4. Elevated PSA (levels ≥ 4 ng/mL), according to local laboratory normal values
• •5. Abnormal serum chemistry values, according to local laboratory normal values that indicate liver or kidney dysfunction or that may be considered clinically significant. Other abnormal lab values may also be exclusionary, at the discretion of the investigator
• •6. Sperm concentration below 15 million/mL in more than one of three screening samples
• •7. Use of androgens or body building substances within 6 months before first screening visit
• •8. Diastolic (D) blood pressure (BP) ≥ 85 and Systolic (S) BP ≥ 135 mm Hg; (BP will be taken 3 times at 5 minute intervals and the mean of all measurements be considered)
• •9. History of hypertension, including hypertension controlled with treatment
• •10. Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis
• •11. Known hypersensitivity to progestins
• •12. Family or personal history of venous thromboembolism
• •13. Benign or malignant liver tumors; active liver disease
• •14. History of breast carcinoma
• •15. Known history of reproductive dysfunction including vasectomy or infertility
• •16. Known history of cardiac, renal, hepatic or prostatic disease
• •17. A serious systemic disease such as diabetes mellitus or morbid obesity (body weight greater than 120% of ideal body weight or BMI limitation as above)
• •18. History of sleep apnea
• •19. Known or suspected alcoholism or drug abuse that may affect metabolism/transformation of steroid hormones and study treatment compliance
• •20. Known dermatitis or severe skin disorder
• •21. Partner is known to be pregnant
• •22. Men desiring fertility within the first 24 weeks of study participation.
• •Men 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.