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

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.

Conditions

• Menopausal Complaints
• Vaginal Atrophy
• Genitourinary Symptoms
• HIV (Human Immunodeficiency Virus)
• Menopause Related Conditions
• Vaginitis
• Perimenopause

Interventions

DRUG

Vaginal estradiol tablets

Using a pre-loaded single-use plastic applicator, participants will insert one 10 microgram estradiol tablet intravaginally daily for 2 weeks and then one tablet twice weekly for the remainder of the study for a total of 16 weeks.

OTHER

Vaginal moisturizer

Using a pre-loaded single-use plastic applicator, participants will insert one vaginal moisturizer applicator intravaginally twice weekly for the duration of the study for a total of 12 weeks.

Sponsors & Collaborators

• Yale University

  collaborator OTHER

• Zymo Research

  collaborator UNKNOWN

• National Institute on Aging (NIA)

  collaborator NIH

• Albert Einstein College of Medicine

  lead OTHER

Principal Investigators

• Kerry J Murphy, MD · Albert Einstein College of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-09-30

Primary Completion

2029-09-30

Completion

2029-10-14

FDA Drug

Yes

Countries

• United States

Study Locations