Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial

Last updated: February 26, 2025
Sponsor: Kerry Murphy
Overall Status: Completed

Phase

4

Condition

Aging

Hiv/aids

Aids And Aids Related Infections

Treatment

Estradiol Vaginal Insert

Clinical Study ID

NCT04079218
2019-10529
1K23AG062400-01A1
  • Ages 45-70
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • HIV infection

  • Females aged 45-70

  • Menopause defined by having no menstrual periods for 12 consecutive months,confirmed with serum follicle-stimulating hormone (FSH) level >40 IU/ml and serumestradiol level <20 pg/ml

  • Symptomatic vaginal atrophy defined as reporting at least once per week in the past 30 days, 1 or more of the following symptoms of moderate or severe intensity:Dryness, Itching, Irritation, Soreness or pain OR Pain associated with sexualactivity at least once

  • Evidence of atrophy on exam, including thin, pale and dry vaginal and vulvarsurfaces

  • Agrees not to use vaginal products other than vaginal estradiol tablet during theclinical trial

Exclusion

Exclusion Criteria:

  • Current or previous history of breast cancer or estrogen dependent neoplasia

  • Current or past thromboembolic disease (deep vein thrombosis or pulmonary embolism,not including thrombophlebitis)

  • Current or previous history of myocardial infarction or stroke

  • Known blood clotting disorders including Protein C, Protein S and antithrombindeficiency, Factor V Leiden or prothrombin mutations

  • Known severe liver disease including cirrhosis or active Hepatitis B

  • History of adverse reaction to vaginal estradiol

  • Current unexplained or unevaluated abnormal genital bleeding

  • Current or suspected pregnancy

  • If < age 55, had a hysterectomy and has at least one ovary

  • Pelvic or vaginal surgery in the prior 60 days

  • Use of systemic reproductive hormones in the past 2 months

  • Antibiotic use in the past 30 days

  • Use of immunosuppressive medications in the prior 60 days including biologics,chemotherapeutics or post-transplant immunosuppressive medications

  • Use of any vaginal or vulvar preparations 1 month prior to enrollment

  • Current active vaginal infection (diagnosed by wet mount at Visit 1 or 2)

  • Any serious disease or chronic condition that might interfere with study compliance

  • Unwilling to agree to the provisions of the protocol

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Estradiol Vaginal Insert
Phase: 4
Study Start date:
September 01, 2020
Estimated Completion Date:
August 09, 2023

Study Description

HIV may be associated with premature aging in the female genital tract including alterations in the vaginal microbiome and mucosal inflammation, which may increase risk for vaginal atrophy, urinary tract infections (UTI) and other genital tract infections. This study will determine whether use of vaginal estradiol for 12 weeks in menopausal women living with HIV with symptomatic vaginal atrophy will improve atrophy symptoms and the vaginal microbiome and reduce mucosal inflammation thereby improving vaginal health. This study will include 50 participants randomized to treatment with a vaginal estradiol insert or no therapy for 12 weeks and will have 4 study visits.

Connect with a study center

  • Albert Einstein College of Medicine

    Bronx, New York 10461
    United States

    Site Not Available

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