Clinical trial NCT02432261 (phase 1, status: completed)
Conditions: healthy
ICD codes: Z76.3, Z76.2
Drugs: nestorone® /testosterone gel, testosterone only gel
SMILES: [H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@]12C, [H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@]12C
Eligibility criteria:

        Inclusion Criteria:

          1. Male volunteers in good health as confirmed by physical examination, medical history,
             and clinical laboratory tests of blood and urine at the time of screening;

          2. 18 to 50 years of age;

          3. BMI < 33 calculated as weight in Kg/(height in cm)2;

          4. No history of hormonal therapy use in the last six months prior to the first screening
             visit;

          5. Subject will agree to use a recognized effective method of contraception with his
             partner (i.e. at a minimum, condom for the male partner and an effective contraception
             for the female partner) during the course of the study treatment and recovery phase;

          6. In the opinion of the investigator, subject is able to comply with the protocol,
             understand and sign an informed consent and HIPAA form;

          7. Does not meet any of the exclusion criteria.

          8. Sperm concentration ≥ 15 million sperm per milliliter ejaculate.

        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 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.