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

StatusNot Yet Recruiting
PhasePhase 4
Started
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Record History

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  1. Primary completion moved earlier from Jun 30, 2031 to Sep 30, 2029v2 Show 4 more changesShow less
    • Start date: Jun 1, 2026 to Sep 2026
    • Study completion moved earlier from Jun 30, 2031 to Oct 14, 2029
    • Secondary endpoint revised
    • Collaborators: 2 to 3
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07526948
Lead Sponsor Albert Einstein College of Medicine
Collaborators: Yale University, Zymo Research, National Institute on Aging (NIA)
Conditions
(from sponsor)		 Menopausal Complaints, Vaginal Atrophy, Genitourinary Symptoms, HIV (Human Immunodeficiency Virus), Menopause Related Conditions, Vaginitis, Perimenopause
Related terms Acquired Immunodeficiency Syndrome, Aging, Premature, Atrophic Vaginitis, Dysbiosis, HIV Infections, Vaginitis
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov