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

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is a prospective, randomized, double-blinded, two-center trial to evaluate the gonadotropin suppressive activity of transdermal treatment with a combined NES/T gel, or T gel alone, for 28 days.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Health Decisions
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Methyltestosterone; ST 1435; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

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.