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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Watson Pharmaceuticals
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

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.