NCT04079218

Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Kerry Murphy · Academic / Other
• Sex: Female
• Age: 45 Years – 70 Years
• Healthy volunteers: Accepted

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.

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 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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-09-01
• Primary completion: 2023-08-09
• Completion: 2023-08-09
• First posted: 2019-09-06
• Last updated: 2025-03-14
• Results posted: 2025-03-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study