At a glance
ClinicalIndex Comparison RecordN/ACompleted· 25 enrolled
Drug / intervention
1 Transdermal Testosterone (Patch) +1 moredrug
Likely dose
Transdermal testosterone 300 micrograms twice a weekAI-extracted
Key inclusion· 5
- ✓Female aged 18–55 years
- ✓HIV-infected
- ✓BMI ≤26
- ✓Androgen deficient with free testosterone <3 pg/mL
Key exclusion· 7
- ✕Use of anabolic agents (testosterone, GH, or similar) within 3 months
- ✕Use of megestrol acetate within 3 months
- ✕Use of estrogen or bone-modifying preparations (oral contraceptives, depo provera, combined progesterone-estrogen injections, transdermal patches)
- ✕Pregnant or breast-feeding
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Androgen Effects in HIV-infected Women
In Brief
A clinical study evaluating 1 Transdermal Testosterone (Patch) and 2 Placebo Patch for HIV Infection. Completed, enrolled 25 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infection
CountriesUnited States
Timeline
N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2004
First PostedNov 2004
Primary CompletionApr 2008
Study CompletionFeb 2009
TodayJul 2026
First PostedNov 2, 2004
Enrollment StartSep 1, 2004
Primary CompletionApr 1, 2008
Study CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 21.7 years ago
Interventions
1 Transdermal Testosterone (Patch)drug
300 micrograms twice a week
2 Placebo Patchdrug
Placebo patch (0 micrograms of testosterone) applied twice a week