Menopausal HT for Women Living With HIV (HoT)
Menopausal Hormone Therapy for Women Living With HIV (HoT)
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
105 participants
Apr 9, 2026
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Inclusion Criteria12
- 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
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Interventions
All participants: Estradiol gel 0.1%, 0.75 grams (corresponding to estradiol 0.75 mg) applied to the skin of the upper thigh once daily for 12 weeks.
Participants with intact uterus: Encapsulated micronized progesterone 100 mg orally once daily for 12 weeks.
All participants: Placebo for estradiol gel 0.1%, 0.75 grams applied to the skin of the upper thigh once daily for 12 weeks.
• Participants with intact uterus: Encapsulated placebo for micronized progesterone 100 mg orally once daily for 12 weeks.
Locations(23)
View Full Details on ClinicalTrials.gov
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NCT06856174