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Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal, HIV-Positive Women

HIV Infections Clinical Trial

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00004400
Study type Interventional
Source FDA Office of Orphan Products Development
Contact
Status Completed
Phase Phase 2
Start date April 1997
Completion date September 2001
View Details
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