Status:
COMPLETED
Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial
Lead Sponsor:
Kerry Murphy
Collaborating Sponsors:
National Institute on Aging (NIA)
Novo Nordisk A/S
Conditions:
HIV Infection
Vaginal Atrophy
Eligibility:
FEMALE
45-70 years
Phase:
PHASE4
Brief 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 a...
Detailed 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 tr...
Eligibility Criteria
Inclusion
- 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 serum estradiol 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 sexual activity at least once
- Evidence of atrophy on exam, including thin, pale and dry vaginal and vulvar surfaces
- Agrees not to use vaginal products other than vaginal estradiol tablet during the clinical trial
Exclusion
- 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 antithrombin deficiency, 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
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04079218
Start Date
September 1 2020
End Date
August 9 2023
Last Update
March 14 2025
Active Locations (1)
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1
Albert Einstein College of Medicine
The Bronx, New York, United States, 10461