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