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

A total of 45 subjects will be enrolled and randomized in a 2:1 ratio to one of two treatment
groups. A description of each group is as follows:

- Group 1 (30 subjects): 5.0 mL of the 1.62% combined gel (containing 8.3 mg NES + 62.5 mg
T) applied each day on the arms and shoulders

- Group 2 (15 subjects): 4.4 mL of the 1.62% AndrogelTM (containing 62.7 mg T) applied
each day to the arms and shoulders

The total duration of treatment will be 28 days followed by a 72 hour sampling period to
assess half-life and a recovery period of at least 28 days, at which point the subjects will
return to the clinic for an end of study visit.

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.