Hormone Therapy for Menopause in Women With HIV

(HoT Trial)

This trial explores whether hormone therapy can help women with HIV who experience bothersome hot flashes and night sweats. Researchers aim to determine if this treatment can also enhance mood, sleep, bone health, heart health, and mental function. The trial uses a hormone gel (transdermal estradiol gel), with some participants also taking a hormone pill (micronized progesterone), depending on whether they have a uterus. Women living with HIV who frequently experience hot flashes or night sweats might be suitable candidates, especially if they are not currently using other treatments for these symptoms. As a Phase 4 trial, this research focuses on understanding how an already FDA-approved and effective treatment can benefit more patients.

You may need to stop taking medications that treat hot flashes or those that cannot be combined with hormone therapy. However, you can continue taking your HIV medications.

Research has shown that transdermal estradiol gel is generally safe for treating menopause symptoms. This form of estrogen can reduce hot flashes and improve sleep, with a lower risk of blood clots compared to estrogen pills, indicating greater safety.

For women with a uterus, adding micronized progesterone balances estrogen's effects. Studies suggest that progesterone can alleviate menopause symptoms without serious side effects.

However, hormone therapy carries risks. Some studies found that taking estrogen without progesterone can increase the risk of endometrial hyperplasia, where the uterine lining thickens. Hormone treatments also pose a general risk of heart disease and stroke, though this risk is lower with skin-applied methods like the gel.

Unlike traditional hormone replacement therapies often taken in pill form, this treatment uses transdermal estradiol gel, offering a unique delivery method that can improve absorption and reduce potential liver strain. Researchers are excited because this approach might offer a safer and more effective way to manage menopause symptoms for women with HIV, who often face additional health challenges. By bypassing the liver, the gel could potentially lower the risk of blood clots and other side effects associated with oral hormone therapies, making it a promising option for a vulnerable group.

This trial will compare hormone therapy with a placebo in women with HIV experiencing menopause. Research has shown that hormone therapy effectively reduces hot flashes and night sweats in menopausal women. Studies have found that a skin-applied estradiol gel, which participants in this trial may receive, can lessen these symptoms and improve sleep. Women using this gel have also reported better memory and fewer feelings of anxiety or depression. Combining estrogen with micronized progesterone, another treatment option in this trial, can further decrease the frequency and severity of these symptoms. Although more research is needed to understand its effects on women with HIV, hormone therapy is generally considered helpful for easing menopause symptoms.¹²³⁴⁶