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Vaginal Estradiol vs. Moisturizer for Menopausal Symptoms in Women with HIV

This research study is looking at how vaginal estradiol tablets compare to a vaginal moisturizer (Replens) in improving menopausal symptoms and the vaginal microbiome (the community of bacteria in the vagina) in women living with HIV. You may be able to join if you are a woman between 40 and 70 years old, have gone through menopause or are in late perimenopause, and have vaginal or urinary symptoms like dryness, irritation, or pain. The study aims to see how these products affect the aging of the female genital tract. The main goal is to measure changes in the vaginal microbiome over 16 weeks. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 62 women. It compares two different vaginal treatments.
What's involved
You would insert either vaginal estradiol tablets for 16 weeks or a vaginal moisturizer for 12 weeks using an applicator. The frequency of use varies by treatment.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes in the vaginal microbiome from baseline to 16 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07526948

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

Not Yet Recruiting
PHASE4Ages 40–70InterventionalTreatment
Albert Einstein College of Medicine
~62 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:Vaginal estradiol tabletsVaginal moisturizer

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in the vaginal microbiome (bacteria) as defined by the change in alpha diversity
Measured over From Baseline to 16 weeks

Conditions

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

Explore related trials

Genitourinary Syndrome of MenopauseHIV InfectionMenopause present

Where it's being run

1 sites across 1 states
New York1

Study leadership

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

Who to contact

Kerry J Murphy, MD
[email protected]
718-839-7885
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

female
at least 40 years old
menopausal (no menses in 12 months) within 2 years of last menstrual period or perimenopausal in the late menopausal transition, defined as an interval of amenorrhea greater than or equal to 60 days
have symptoms of the genitourinary syndrome of menopause (GSM) which developed within the prior 2 years. Symptoms of GSM include vaginal symptoms including dryness, soreness, itching, irritation and dyspareunia and/or urinary symptoms including urgency, frequency and recurrent urinary tract infections (UTIs)

Exclusion

Unexplained or unevaluated abnormal genital bleeding
Current or suspected pregnancy
Desired pregnancy
If less than 55 years old, have had a hysterectomy and have at least one ovary (as menopause cannot be determined in this case by amenorrhea alone)
Pelvic or vaginal surgery in the prior 60 days
Used systemic reproductive hormones in the last 2 months
Used antibiotics in the last 30 days
Used immunosuppressive medications in the prior 60 days including biologics, chemotherapeutics or post transplant immunosuppressive medications
Used any vaginal or vulvar preparations in the last month
Current active vaginal infection diagnosed at study entry
Any serious disease or condition that may interfere with study compliance
Current or previous history of breast cancer or estrogen dependent cancer (e.g., ovarian, endometrial)
Current or previous history of deep vein thrombosis or pulmonary embolism
Current or previous history of myocardial infarction or stroke
Known clotting disorder including Protein C, Protein S and antithrombin deficiency, Factor V Leiden or prothrombin mutations
Known severe liver disease including cirrhosis or active Hepatitis B
Known allergic reaction to Vagifem (estradiol vaginal tablet) or Replens

What this trial measures

  • Change in the vaginal microbiome (bacteria) as defined by the change in alpha diversityFrom Baseline to 16 weeks

    Changes in the vaginal microbiome as defined by the change in alpha diversity from baseline to 16 weeks will be assessed. It is hypothesized that this may be a biomarker for improvement in vaginal health. Lower alpha diversity would indicate a favorable change in the microbiome.