Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal, HIV-Positive Women
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00004400|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Cachexia||Drug: testosterone||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Study Start Date :||April 1997|
|Study Completion Date :||September 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|