Clinical Trial

Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV

Not Yet Recruiting Phase 4
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Summary
This is a research study about the effects of vaginal estradiol compared to moisturizer on vaginal symptoms of menopause and the microbiome in women with HIV. This research study aims to understand how vaginal products affect the aging of the female genital tract in women living with HIV who are menopausal or perimenopausal and have vaginal or urinary symptoms. There is a comparison group of women who are living without HIV. Participants with HIV and vaginal or urinary menopausal symptoms (e.g., dryness, irritation, soreness, itching, pain with sex, dysuria, urgency, or frequent urinary tract infections) will be asked to apply vaginal estradiol or a vaginal moisturizer (Replens). Participants who have vaginal or urinary menopausal symptoms and do not have HIV will receive vaginal estradiol.
Protocol Amendment History 2 changes
notable Primary completion moved earlier: 2031-06-30 -> 2029-09-30 2026-07-29
minor Completion moved earlier: 2031-06-30 -> 2029-10-14 2026-07-29
Trial Details
NCT Number NCT07526948
Lead Sponsor Albert Einstein College of Medicine
Collaborators: Yale University, Zymo Research, National Institute on Aging (NIA)
Conditions Menopausal Complaints, Vaginal Atrophy, Genitourinary Symptoms, HIV (Human Immunodeficiency Virus), Menopause Related Conditions, Vaginitis, Perimenopause
Enrollment 62 participants
Start Date 2026-09
Primary Completion 2029-09-30 (estimated)
Study Completion 2029-10-14 (estimated)
Updated on ClinicalTrials.gov 2026-07-28