NCT06856174

Menopausal HT for Women Living With HIV (HoT)

Menopausal Hormone Therapy for Women Living With HIV (HoT)

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Network
• Sex: Female
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

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

Conditions

• HIV Infection
• Menopause

Interventions

Type	Name	Description
DRUG	Transdermal estradiol gel	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.
DRUG	Micronized Progesterone	Participants with intact uterus: Encapsulated micronized progesterone 100 mg orally once daily for 12 weeks.
DRUG	Placebo for estradiol gel	All participants: Placebo for estradiol gel 0.1%, 0.75 grams applied to the skin of the upper thigh once daily for 12 weeks.
DRUG	Placebo for micronized progesterone	• Participants with intact uterus: Encapsulated placebo for micronized progesterone 100 mg orally once daily for 12 weeks.

Timeline

• Start date: 2026-04-30
• Primary completion: 2027-09-20
• Completion: 2027-09-20
• First posted: 2025-03-04
• Last updated: 2026-04-07

Regulatory

• FDA-regulated drug study