Dose Titration Investigation of the Pharmacokinetics of Testosterone Transdermal Systems in Hypogonadal Men

An Open Label, Dose-Titration Investigation of the Pharmacokinetics, Metabolism and Safety of Testosterone Transdermal Systems in Hypogonadal Men

The study will evaluate the pharmacokinetics of testosterone transdermal systems at steady-state in hypogonadal men.

Subjects will receive testosterone for 4 weeks. Based on a single morning testosterone measurement performed at the end of Week 1, the dosage can be titrated up or down to the next dose level to maintain testosterone levels in the normal range. At the end of 4 weeks of treatment, a pharmacokinetic profile for total testosterone and metabolites will be obtained.

Inclusion Criteria:

• Males in good general health, 18 years of age or older.
• Have a previously documented testosterone deficiency.
• Willing and able to comply with the requirements of the protocol.

Exclusion Criteria:

• Have a history of intolerance to Androderm or other testosterone products.
• Prostate specific antigen (PSA) level ≥ 4.0 ng/mL
• Prostate cancer or severe benign prostatic hypertrophy (BPH)
• Have significant abnormalities in the physical examination at screening.
• Have current dermatological disease, skin damage or blemishes.
• Have participated in an investigational drug study within 30 days prior to screening.