Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal, HIV-Positive Women
- Conditions
- HIV InfectionsCachexia
- Registration Number
- NCT00004400
- Lead Sponsor
- Charles Drew University of Medicine and Science
- Brief Summary
OBJECTIVES: I. Determine whether physiologic testosterone replacement can increase fat-free mass, therefore contributing to weight maintenance, improved muscle function, and quality of life in HIV-infected women.
II. Examine the mechanism of testosterone-induced increase in fat-free mass.
- Detailed Description
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are randomized to one of three arms.
Arm I: Patients receive two placebo transdermal patches applied twice a week (every 3-4 days).
Arm II: Patients receive one testosterone transdermal patch and one placebo transdermal patch applied twice a week (every 3-4 days).
Arm III: Patients receive two testosterone transdermal patches applied twice a week (every 3-4 days).
Patients receive 12 weeks of treatment in the absence of adverse reaction or health deterioration. Patients are followed on day 1, every 2 weeks during treatment, and at the end of the recovery period. Quality of life is assessed before treatment begins and at weeks 6 and 12.
Completion date provided represents the completion date of the grant per OOPD records
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 56
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Charles R. Drew University of Medicine and Science
🇺🇸Los Angeles, California, United States
Los Angeles County Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Charles R. Drew University of Medicine and Science🇺🇸Los Angeles, California, United States