Phase 4 N=60 Randomized Treatment

Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial

HIV Infection · Vaginal Atrophy · Menopause · Menopause Related Conditions · Aging

Bottom Line

View on ClinicalTrials.gov: NCT04079218 ↗

Enrolled (actual)

Serious AEs

10.0%

Results posted

Mar 2025

Primary outcome: Primary: Change in Most Bothersome Symptom (MBS) of Vaginal Atrophy — 0; 1; 8; 4 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Estradiol Vaginal Insert (Drug)
Age: Adult, Older Adult · 45+ yrs
Sex: Female
Sponsor: Kerry Murphy
Primary completion: Aug 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Most Bothersome Symptom (MBS) of Vaginal Atrophy	0; 1; 8; 4; 0; 1	—
PRIMARY Vaginal Microbiome - Relative Abundance of Lactobacillus Crispatus (L. Crispatus)	-1.37; -6.9	—
PRIMARY Vaginal Microbiome - Quantitative Determination of Protective Lactobacilli Species	—	—
SECONDARY Vaginal Microbiome - Relative Abundance of Bacterial Vaginosis Associated Species	3.15; -1.22; -5.17; -1.14; -0.82; -1.09	—
SECONDARY Vaginal Microbiome - Quantitative Determination of Bacterial Vaginosis Associated Species	—	—
SECONDARY Change in Vaginal Cytokine and Chemokine Concentrations	0.17; -0.07; -0.07; 0.11; -0.04; 0.02	—

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 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 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 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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04079218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.