A Clinical Study to Evaluate the Pharmacokinetics of Testosterone Gel Using an Applicator
A Clinical Study to Evaluate the Pharmacokinetics of Testosterone Gel Using an Applicator
This is a Phase 2 clinical trial in adult hypogonadal males with baseline morning serum
 testosterone concentrations <300 ng/dL. The purpose of this study is to evaluate the
 pharmacokinetics of FE 999303, delivered using an applicator in comparison to hand
 application
Inclusion Criteria:

 -  Ages 18-75

 -  History of hypogonadism

 -  In good health based on medical history, physical examination, and clinical laboratory
 tests

 -  Serum testosterone deficiency

 -  One or more symptom(s) of testosterone deficiency (i.e. fatigue, reduced libido, or
 reduced sexual functioning)

 -  Body mass index (BMI) between 18 and 35 kg/m^2

 -  All screening lab tests within 20% of the normal range (exceptions are liver function
 tests)

 -  HIV, Hepatitis B and C negative

 Exclusion Criteria:

 -  Previous use of FE 999303

 -  Prostate cancer

 -  Breast carcinoma, patient or partner

 -  Palpable prostatic mass(es)

 -  Serum PSA levels ≥3 ng/dL

 -  Chronic use of any drug of abuse

 -  Lower urinary tract obstruction

 -  Clinically significant anemia or renal dysfunction

 -  Cardiovascular disease

 -  Hyperparathyroidism or uncontrolled diabetes

 -  Generalized skin irritation or significant skin disease

 -  Use of any medications that could be considered anabolic (e.g. dehydroepiandrosterone
 (DHEA)) or could interfere with androgen metabolism (e.g. spironolactone,
 5-alfa-reductase-inhibitors, ketoconazole, abiraterone)

 -  Use of estrogens, GnRH agonists/antagonist, antiandrogens, human GH (within previous
 12 months of screening)

 -  Use of testosterone products (within 8 weeks of screening for parenteral products, or
 6 weeks of screening for other preparations)

 -  Sleep apnea

 -  Untreated depression

 -  Subject with a partner who is pregnant or will not use contraception