Can vaginal estradiol or moisturizer ease menopause symptoms in women with HIV?
NCT ID NCT07526948
First seen Jun 24, 2026 · Last updated Jul 29, 2026 · Updated 3 times
Summary
This study compares vaginal estradiol tablets (Vagifem) to a vaginal moisturizer (Replens) for treating menopause-related vaginal and urinary symptoms in women living with HIV. Researchers will also check how these treatments affect the vaginal microbiome. The study includes 62 participants, some with HIV and some without, and lasts 16 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- vaginal estradiol (Vagifem) and vaginal moisturizer (Replens)
- What this could lead to
- If it works, this could point toward a safe way to ease menopause symptoms and improve vaginal health in women living with HIV.
- What could go wrong
- This is a small, early-phase study with only 62 participants. Results may not apply to all women, and the benefits of estradiol or moisturizer may be modest.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 62 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 70 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
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