A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel

A Phase 3, Open-label, Non-randomized, Clinical Trial to Evaluate the Efficacy and Safety of FE 999303 (Testosterone Gel) in Adult Hypogonadal Males

This is a Phase 3 clinical trial in adult hypogonadal males with baseline serum testosterone concentrations <300 ng/dL. The purpose of this study is to evaluate the safety and efficacy of testosterone gel (2%) delivered using an applicator.

Inclusion Criteria:

1. Males between 18-75 years of age
2. Two screening serum testosterone values less than 300 ng/dL
3. One or more symptoms of testosterone deficiency

Exclusion Criteria:

1. Previous use of the investigational product
2. Use of any investigational product within 30 days prior to screening and during the study
3. BMI less than 18 kg/m^2 or more than 35 kg/m^2
4. Prostatic mass(es)
5. Generalized skin irritation or skin disease
6. Lower urinary tract obstruction
7. Myocardial infarction or cerebrovascular accident in the last 6 months
8. Unstable angina or congestive heart failure
9. Thromboembolic disorders
10. Sleep apnea
11. Hyperparathyroidism or uncontrolled diabetes
12. Untreated moderate to severe depression
13. History of testicular, prostate, or breast cancer
14. HIV, Hepatitis B, or Hepatitis C positive
15. PSA more or equal to 3 ng/mL
16. Use of any medications that could be considered anabolic
17. Use of estrogens, Gonadotropin Releasing Hormone agonists/antagonists, antiandrogens, or human Growth Hormone
18. Chronic use of any drug of abuse
19. Involvement in a sport in which there is a screening for anabolic steroids
20. Not willing to use adequate contraception during the study
21. Partner is pregnant and/or breast feeding
22. Partner has a history of breast, uterine or ovarian cancer