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

Watson Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Hypogonadism

Treatments

Drug: Testerone Transdermal System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01104246

AND1001

Details and patient eligibility

About

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

Full description

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.

Enrollment

40 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.