Efficacy, Pharmacokinetics and Safety of Testosterone
Efficacy, Pharmacokinetics and Safety of Testosterone
This is an open-label study of a single and repeated application of three dose levels of
 topical testosterone in hypogonadal males with morning serum testosterone concentrations <
 297 ng/dL.
Inclusion Criteria:

 -  Ages 18-65

 -  History of hypogonadism

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

 -  Screening morning serum testosterone ≤ 297 ng/dL

 -  One or more symptoms of testosterone deficiency (i.e. fatigue, reduced libido or
 reduced sexual functioning of non-vasculogenic or neurogenic nature)

 -  Body mass index (BMI) between 18 and 31

 Exclusion Criteria:

 -  Prostate cancer

 -  Palpable prostatic mass(es)

 -  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, finasteride,
 ketoconazole)

 -  Clinically significant anemia or renal dysfunction

 -  Hyperparathyroidism or uncontrolled diabetes

 -  Serum PSA Levels; ≥ 4ng/mL

 -  History of cardiovascular disease

 -  Use of estrogens, Gonadotropin-releasing hormone (GnRH) agonists/antagonist, human
 growth hormone (hGH), (within previous 12 months)

 -  Use of testosterone products (within eight months for parenteral products, or six
 weeks for other preparations)