Study of the Safety, and Sperm and Gonadotropin Suppression of a Contraceptive Gel in Normal Men
Condition: Contraception
Intervention: Testosterone; Nestorone®; Nestorone®; Nestorone®
Intervention description: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.; Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head.; Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.; Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.
Intervention MeSH terms: ST 1435; Testosterone
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 99.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Contraception; Male Contraception; Suppression of Sperm Production

Summary:

      To determine the number of men who have suppression of sperm production when using a daily
      regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel applied transdermally.
    

Eligibility criteria:

        Inclusion Criteria

        Men who meet all the following criteria are eligible for enrollment in the trial:

          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, use double-barrier contraception) 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.

        Exclusion Criteria:

        Men who meet any of the following criteria are NOT eligible for enrollment in the trial:

          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.