N/A
N=25
Androgen Effects in HIV-infected Women
HIV Infection
Bottom Line
View on ClinicalTrials.gov: NCT00095212 ↗Enrolled (actual)
25
Serious AEs
8.0%
Results posted
Mar 2010
Primary outcome: Primary: Lean Body Mass — 1.8; 0.8 kilograms — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 1 Transdermal Testosterone (Patch) (Drug); 2 Placebo Patch (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lean Body Mass |
1.8; 0.8 | 0.04 sig |
| SECONDARY Bone Mineral Density of the Hip |
0.01; -0.01 | 0.02 sig |
| SECONDARY Quality of Life/Depression: Becks Depression Inventory |
-6.8; -1.9 | 0.02 sig |
| SECONDARY Quality of Life/Sexual Function: Brief Index of Sexual Function (BISF-W) Domain 7: Problems Affecting Sexual Function |
-1.8; 0.5 | 0.01 sig |
| SECONDARY Safety: Number of Subjects Reporting a Skin Reaction to the Patch |
4; 1 | 0.16 |
| SECONDARY Safety: Number of Subjects Reporting a Change in Hair Pattern (Increased Hair on Chin, Upper Lip, Chest, Abdomen, Fore Arms, and Legs) |
2; 4 | 0.29 |
| SECONDARY Safety: Number of Subjects Reporting Acne |
4; 3 | 0.75 |
| SECONDARY Safety: Number of Subjects Reporting a Change in Menstrual Status (Reported More Than One Period in 1 Month or Missed a Period During a Monthly Cycle) |
6; 9 | 0.14 |
| SECONDARY Neurocognitive Function: Hopkins Verbal Learning Test-revised,"Total Recall" Z Score Represents Change in Z Score From Baseline to 18 Months. |
-0.21; 0.50 | 0.26 |
| SECONDARY Strength: Total Knee Flexion Performed Via Quantitative Muscle Function Testing. |
28.5; 11.0 | 0.22 |
| SECONDARY Strength: Total Knee Extension Performed Via Quantitative Muscle Function Testing. |
28.0; 26.9 | 0.94 |
Summary
Androgen deficiency in HIV-infected women is associated with sarcopenia and may cause critical reductions in physical functioning and reduced bone density. The effects of long-term androgen therapy on lean body mass, bone density and other clinical endpoints including quality of life, functional status and neurocognitive function in HIV-infected women are not known.
Eligibility Criteria
Inclusion Criteria
- Female 18 - 55
- BMI less than or equal to 26
- HIV-infected
- Androgen deficient, with free testosterone 1.5 mg/dL
Data sourced from ClinicalTrials.gov (NCT00095212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.