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Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial

NCT04079218 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-03-14

Study results available
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Summary

During menopause, there is a decrease in a hormone estrogen, which leads to aging of the vagina. Vaginal aging includes changes in the type and amount of healthy bacteria in the vagina, inflammation and a breakdown of natural barriers that keep the vagina healthy and protected from infections. Some menopausal women develop a condition called vaginal atrophy, which causes vaginal dryness, irritation, pain with sex, and itching. We are testing whether an estradiol tablet placed inside the vagina will lead to fewer changes in the types of bacteria present in the vagina, improve vaginal atrophy symptoms and ultimately keep the vagina healthier for a longer. This is important for women with HIV as they are living longer, healthier, sexually active lives due to successful treatment with antiretrovirals.

Conditions

  • HIV Infection
  • Vaginal Atrophy
  • Menopause
  • Menopause Related Conditions
  • Aging
  • Premature Aging
  • Atrophic Vaginitis
  • Dysbiosis
  • Vaginitis

Interventions

DRUG

Estradiol Vaginal Insert

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 12 weeks.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • Irma L and Abram S Croll Charitable Trust

    collaborator UNKNOWN

  • Kerry Murphy

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2023-08-09
Completion
2023-08-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04079218 on ClinicalTrials.gov