Menopausal HT for Women Living With HIV (HoT)

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

January 19, 2026

Primary Completion Date

September 20, 2027

Study Completion Date

September 20, 2027

Conditions
HIV InfectionMenopause
Interventions
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.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

National Institute on Aging (NIA)

NIH

collaborator

Exeltis

INDUSTRY

collaborator

Xiromed LLC

INDUSTRY

lead

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NETWORK