Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Men

Exclusion Criteria

• •8. Sperm concentration ≥ 15 million sperm per milliliter ejaculate.
• •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 physical 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;
• •6. Use of androgens or body building substances within 6 months before first screening visit;
• •7. Diastolic blood pressure (DBP) \> 80 and/or Systolic (SBP) \> 130 mm Hg;
• •8. EKG abnormal and clinically significant and QTC level longer than 450msec;
• •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 or androgen;
• •12. Family or personal history of venous thromboembolism;
• •13. Benign or malignant liver tumors; active liver disease;
• •14. Known history of reproductive dysfunction including vasectomy or infertility;
• •15. Known history of cardiovascular, renal, hepatic or prostatic disease;
• •16. 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);
• •17. Known or suspected alcoholism or drug abuse that may affect metabolism/transformation of steroid hormones and study treatment compliance;
• •18. Known dermatitis or severe skin disorder;
• •19. Moderate or severe depression as determined by PHQ-9 score \>15;
• •20. Partner is known to be pregnant;
• •21. Known or suspected breast or prostate cancer;
• •22. Allergic to any ingredient in testosterone/nestorone gel, including alcohol;
• •23. Known history of untreated sleep apnea;
• •24. International Prostate Symptom Score (IPSS) greater than or equal to 15.