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

Part of paid clinical trials in The Bronx, New York.

Sponsor
Albert Einstein College of Medicine
Study ID
NCT07526948
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Vaginal estradiol tablets — DRUG
    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.
  • Vaginal moisturizer — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2031
Completion
Jun 30, 2031

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Vaginal Estradiol, Participants Living With HIV
    Participants living with HIV randomized to this arm will use vaginal estradiol tablets for the duration of the study (16 weeks)
  • Active Comparator: Vaginal Estradiol, Participants without HIV
    Participants without HIV enrolled in the study will use vaginal estradiol tablets for the duration of the study (16 weeks). A control group of women without HIV with GSM (n=12) will be treated with vaginal estradiol for 16 weeks but will not be randomized to moisturizer as topical estrogen has already been shown (and is FDA approved) to improve symptoms and the vaginal microbiome in women without HIV infection.
  • Active Comparator: Vaginal Moisturizer, Participants Living with HIV
    Participants living with HIV randomized to this group will use vaginal moisturizer for the duration of the study (16 weeks)

Primary Outcome Measure

Change in the vaginal microbiome (bacteria) as defined by the change in alpha diversity [ Time Frame: From Baseline to 16 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Albert Einstein College of MedicineThe BronxNew York10461
Kerry J Murphy, MD
[email protected]
718-839-7885

Find similar trials in The Bronx, NY

By condition
Menopause
By specialty
Women's healthFertility
By research site
Albert Einstein College of Medicine· The Bronx, NY

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