Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal, HIV-Positive Women
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
|Study Start Date:||April 1997|
|Estimated Study Completion Date:||September 2001|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004400
|United States, California|
|Charles R. Drew University of Medicine and Science|
|Los Angeles, California, United States, 90059|
|Los Angeles County Harbor-UCLA Medical Center|
|Torrance, California, United States, 90509|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Study Chair:||Shalender Bhasin||Charles Drew University of Medicine and Science|