Study of Spermatogenesis Suppression With DMAU Alone or With LNG Versus Placebo Alone in Normal Men

Exclusion Criteria

• •1. Men participating in another clinical trial involving an investigational drug within the 30 days prior to the first screening visit.
• •2. Men not living in the catchment area of the clinic or within a reasonable distance from the study site.
• •3. Clinically significant abnormal physical or laboratory findings at screening.
• •4. Elevated PSA (levels ≥ 2.5 ng/mL) at screening, according to local laboratory normal values.
• •5. IPSS score ≥ 10.
• •6. Abnormal serum chemistry values at screening, according to local laboratory reference ranges that indicate liver or kidney dysfunction or that may be considered clinically significant. In addition, the following upper limits will be observed: fasting bilirubin less than 2 mg/dL, cholesterol less than 221 mg/dL, and fasting triglycerides less than 201 mg/dL.
• •7. Abnormal semen analyses or abnormal semen concentration as defined by the WHO semen manual (\< 15 million/mL).
• •8. Use of androgens within 3 months before first screening visit except for long acting testosterone which requires a wash out period of 4 months prior to screening.
• •9. Ongoing use of androgens or other compounds for body building including nutritional supplements.
• •10. Systolic BP ≥130 mm Hg and Diastolic blood pressure BP ≥ 80 and mm Hg; Blood pressure (BP) will be taken 3 times at 5 - minute intervals and the mean of second and third measurements will be used to determine eligibility. (Note: Diagnosis of hypertension or treatment of hypertension is exclusionary.)
• •11. PHQ-9 score of 15 or above.
• •12. History of hypertension, including hypertension controlled with treatment.
• •13. Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis.
• •14. Benign or malignant liver tumors; active liver disease.
• •15. History of breast carcinoma.
• •16. Known history of androgen deficiency due to hypothalamic-pituitary or testicular disease.
• •17. Known history of cardiovascular, renal, hepatic or prostatic disease or significant psychiatric illness.
• •18. Positive serology for active Hepatitis (not immunization-related serology) or HIV at screening visit.
• •19. A serious systemic disease such as diabetes mellitus.
• •20. History of known, untreated sleep apnea.
• •21. Partner is known to be pregnant.
• •22. Men desiring fertility within 12 months of signing consent for study participation.
• •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) from 12-week daily use of DMAU.
• •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 medications that will interfere or interact with DMAU or LNG.
• •26. Known hypersensitivity to any of the active substances of DMAU, of the excipients of the study treatment, or LNG.