Study of Daily Application of Nestorone® (NES) and Testosterone (T) Combination Gel for Male Contraception

Exclusion Criteria

• •1. Men participating in another clinical trial involving an investigational drug within the last 30 days (or within five half-lives of the investigational drug, whichever is longer) prior to the first screening visit.
• •2. Men not living in the catchment's area of the study site or within a reasonable distance from the site.
• •3. Clinically significant abnormal findings at screening per the Investigator's medical judgment.
• •4. Elevated PSA levels ≥ 4 ng/mL.
• •5. Abnormal serum chemistry values that may indicate clinically significant liver or kidney dysfunction.
• •6. Use of androgens or other anabolic steroids that may suppress gonadotropins within 6 months prior to the first screening visit.
• •7. Diastolic blood pressure (DBP) ≥ 85 and Systolic blood pressure (SBP) ≥ 135 mm Hg; (BP will be taken three times at approximately 5 minute intervals and the mean of the 2 measurements will be used to determine eligibility).
• •8. History of hypertension, including hypertension controlled with treatment.
• •9. Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis.
• •10. Known hypersensitivity to progestins or testosterone or any excipient of the investigational product.
• •11. History of prostate, testicular or breast carcinoma.
• •12. Significant prostatic symptoms (IPSS \> 15).
• •13. Known history of reproductive dysfunction including vasectomy or infertility.
• •14. Known history of significant cardiac, renal, hepatic or prostatic disease.
• •15. History of thromboembolic disease.
• •16. A serious systemic disease such as diabetes mellitus (including diabetes controlled with treatment), HIV/AIDS;
• •17. Current active or ongoing Hepatitis infection.
• •18. History of untreated sleep apnea.
• •19. Known or suspected current alcohol dependence syndrome, chronic marijuana use, or any illicit drug use that may affect metabolism/transformation of steroid hormones and study treatment compliance.
• •20. Any skin condition that might interfere with absorption of gel.
• •21. Couples desiring fertility within the study participation period (approximately 104 weeks from screening to end of recovery).
• •22. PHQ9 score ≥10, a score ≥1 on Question #9 on the PHQ9, or history of severe depression or other serious mental health disorder, including ongoing use of an anti-depressant.
• •23. Men participating in competitive sports where drug screening for prohibited substances (including anabolic steroids) is routine. Exclusion is due to the potential of testing positive for androgens that may occur from their study participation coupled with the unknown efficacy (i.e. duration of positive testing) of a single application.
• •24. Use of sex steroids or medications which might interfere with steroid metabolism (i.e., ketoconazole, finasteride, oral corticosteroids, dutasteride, and statins).
• •25. Use of anticoagulants.
• •26. Use of medications that will interfere or interact with Nestorone or Testosterone.
• •27. Use of oily cosmetic skin gels/products that would prevent absorption of steroids.
• •28. Previous participation in this clinical trial.
• •29. Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities.
• •30. Have issues or concerns (in the judgment of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study.
• •1. Desire to become pregnant during the study.
• •2. Breastfeeding.
• •3. Known or suspected current alcoholism or drug abuse.
• •4. Participation in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit.
• •5. Currently pregnant.
• •6. Known hypersensitivity to progestins or testosterone.
• •7. Previous participation in this clinical trial.
• •8. Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities.
• •9. Have issues or concerns (in the judgment of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study.