Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial
United States60 participantsStarted 2020-09-01
Plain-language 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.
Who can participate
Age range
45 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 m…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Most Bothersome Symptom (MBS) of Vaginal Atrophy
Timeframe: Between baseline (Visit 2) and 12 weeks (Visit 5)
2
Vaginal Microbiome - Relative Abundance of Lactobacillus Crispatus (L. Crispatus)
Timeframe: Between baseline (Visit 2) and 6 weeks and 12 weeks (Visit 5)
3
Vaginal Microbiome - Quantitative Determination of Protective Lactobacilli Species
Timeframe: Between baseline (Visit 2) and 6 weeks and 12 weeks (Visit 5)