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

Completed · Phase 1

Conditions studied: Hypogonadism

In brief

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

Key facts

Study ID

NCT01104246

Run by

Watson Pharmaceuticals

People needed

40

Starts

2010-04-01

Expected to finish

2010-09-01

Last updated by the study team

2012-10-05

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Watson investigational site — Miramar, Florida, United States
• Watson investigational site — Omaha, Nebraska, United States
• Watson investigational site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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