NCT00004400

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Charles Drew University of Medicine and Science · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Conditions

• HIV Infections
• Cachexia

Interventions

Type	Name	Description
DRUG	testosterone

Timeline

• Start date: 1997-04-01
• Completion: 2001-09-01
• First posted: 1999-10-19
• Last updated: 2015-03-25

Locations

3 sites across 1 country: United States