Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial

Aging Clinical Trial

Official title: The Impact of HIV on Accelerated Aging in the Female Genital Tract: a Pilot Trial of Topical Estradiol to Improve the Vaginal Microbiome and Symptoms of Vaginal Atrophy in Menopausal Women With HIV

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT04079218
• Study type: Interventional
• Source: Albert Einstein College of Medicine
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2020
• Completion date: August 9, 2023