EligibleTrials
Conditions › HIV › NCT06856174

Menopausal HT for Women Living With HIV (HoT)

Recruiting · NCT06856174 · Interventional (participants receive a specific treatment) · Lead sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

View the official record on ClinicalTrials.gov →
HIV

Interventions studied

Micronized ProgesteronePlacebo for estradiol gelPlacebo for micronized progesteroneTransdermal estradiol gel

What this trial is about

Women living with HIV have been shown to experience more frequent and severe hot flashes and night sweats (collectively known as vasomotor symptoms) as compared to women living without HIV. This correlates with disturbed sleep, increased depressive symptoms, increased anxiety, worse mental function, interference with activities of daily living including work, and worse overall quality of life. Hormone therapy is considered to be the most effective therapy for hot flashes and night sweats and the most appropriate choice to prevent bone loss at the time of menopause for women without HIV. However, the usefulness of hormone therapy has not been specifically studied in women living with HIV. This trial is being done to see if: * There is evidence to support the use of hormone therapy (estradiol with or without progesterone) for the treatment of hot flashes and night sweats in women living with HIV * Hormone therapy improves mental function, mood, sleep, quality of life, bone health, heart health, and inflammation in women living with HIV * Hormone therapy is safe and tolerable for women living with HIV

Who can take part

Age range
40 Years to 60 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)

Eligibility criteria (as published)

* Living with HIV * Assigned female sex at birth * Between the ages of 40 and 60 years * In the late menopausal transition (perimenopause) or early postmenopause * Experiencing hot flashes and/or night sweats * Willing and able to complete a daily diary * Does not have medical condition that would contraindicate hormone therapy * Not taking medications to treat hot flashes * Not taking medications that cannot be combined with hormone therapy * Receiving antiretrovirals (HIV medication) for more than 1 year * Not pregnant and willing and able to use at least non-hormonal birth control to prevent pregnancy * Willing and able to provide informed consent after discussion with the research staff

Where it is running

23 locations listed across 14 US states.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →

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