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

Information source: Watson Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypogonadism

Intervention: Testerone Transdermal System (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Watson Pharmaceuticals

Official(s) and/or principal investigator(s):
Keshava Kumar, PhD, MHSA, Study Director, Affiliation: Watson Laboratories


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

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours

Detailed 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.


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.

Locations and Contacts

Watson investigational site, Miramar, Florida 33025, United States

Watson investigational site, Omaha, Nebraska 68184, United States

Watson investigational site, San Antonio, Texas 78209, United States

Additional Information

Starting date: April 2010
Last updated: October 2, 2012

Page last updated: August 23, 2015

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