Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Aging
- Atrophic Vaginitis
- Dysbiosis
- HIV Infection
- Menopause
- Menopause Related Conditions
- Premature Aging
- Vaginal Atrophy
- Vaginitis
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants will be randomly assigned to receive treatment with estradiol vaginal tablets or no treatment.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 45 years and 70 years
- Gender
- Only males
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 va...
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.
Tracking Information
- NCT #
- NCT04079218
- Collaborators
- National Institute on Aging (NIA)
- Novo Nordisk A/S
- Investigators
- Principal Investigator: Kerry J Murphy, MD Albert Einstein College of Medicine
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