Hormone therapy for menopause in women living with HIV
Hormone Therapy for Peri- and Postmenopausal Women with HIV (HoT)
This trial tests whether hormone therapy (skin estrogen plus oral progesterone) reduces hot flashes and night sweats in peri- and early postmenopausal women living with HIV.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Columbia University Health Sciences NIH-funded |
| Lab location | 1 site (New York, United States) |
| Project ID | NIH-11171780 on NIH RePORTER |
What this research studies
You would be randomly assigned in a double-blind, placebo-controlled 2x2 crossover trial of 80 peri- and early postmenopausal women living with HIV to receive transdermal estrogen plus oral progesterone or matching placebos. The study tracks how hormone therapy changes the frequency and severity of hot flashes and night sweats and uses tests and questionnaires to look at thinking, mood, sleep, and quality of life. Blood tests will measure markers of bone and cardiometabolic health and inflammation to see if hormone therapy affects those risks. The trial will also measure effects on the HIV reservoir using a specialized EDITS assay.
Who could benefit from this research
Good fit: Peri- and early postmenopausal women living with HIV who are bothered by hot flashes and night sweats and can attend study visits.
Not a fit: People who are not peri- or postmenopausal, people without HIV, or anyone with contraindications to hormone therapy (for example a history of estrogen-sensitive cancer or blood clots) may not benefit or be eligible.
Why it matters
Potential benefit: If successful, this could reduce hot flashes and night sweats and improve mood, sleep, bone and heart health for women with HIV during menopause.
How similar studies have performed: Hormone therapy is a proven treatment for hot flashes in women without HIV, but it has not previously been tested in women living with HIV.
Where this research is happening
New York, United States
- Columbia University Health Sciences — New York, United States (Active)
Researchers
- Principal investigator: Yin, Michael T — Columbia University Health Sciences
- Study coordinator: Yin, Michael T
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.