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NCT07526948 · ClinicalTrials.gov registry record · Phase 4
Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV
A Phase 4 study, sponsored by Albert Einstein College of Medicine.
- Not yet
- Registry status
- Phase 4
- Development phase
- 62
- Enrollment target
NCT07526948: Clinical Trial Phase 4 study, sponsored by Albert Einstein College of Medicine.
NCT07526948 is a Phase 4 study that has not yet begun recruiting, run by Albert Einstein College of Medicine. The registered enrollment target is 62 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07526948, a Phase 4 study, has not yet begun recruiting, sponsored by Albert Einstein College of Medicine.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 62 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Vaginal estradiol tablets
- OTHER Vaginal moisturizer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2026-06-01 |
| Est. Completion | 2031-06-30 |
| Phase | Phase 4 |
What is known before NCT07526948 opens enrollment
NCT07526948 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Vaginal estradiol tablets is the first listed.
NCT07526948 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07526948 about?
NCT07526948 is a clinical study titled "Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV". 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 men...
What is the current status of trial NCT07526948?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 62 participants. The study started on 2026-06-01. Estimated completion is 2031-06-30.
What interventions are being tested in trial NCT07526948?
The interventions under investigation include: Vaginal estradiol tablets (DRUG), Vaginal moisturizer (OTHER).
Who is sponsoring clinical trial NCT07526948?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07526948's enrollment target sits among peer trials
62 1110th of 2000 higher than 882 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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