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Hormone Therapy
Estradiol for Menopause-Related Vulvovaginal Atrophy in HIV
Phase 4
Waitlist Available
Led By Kerry J Murphy, MD
Research Sponsored by Albert Einstein College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 and 12 weeks
Awards & highlights
Study Summary
This trial is testing whether an estradiol tablet can help reduce the changes in vaginal bacteria and improve symptoms of vaginal atrophy in menopausal women.
Who is the study for?
This trial is for HIV-positive women aged 45-70 who are postmenopausal, experiencing symptoms like vaginal dryness or pain during sex due to vaginal atrophy. Participants must not use other vaginal products during the study and should have no history of blood clotting disorders, severe liver disease, certain cancers, thromboembolic disease, recent surgeries or use of hormones.Check my eligibility
What is being tested?
The trial tests if an estradiol tablet inserted into the vagina can improve symptoms of vaginal atrophy in menopausal women with HIV. It aims to see if this treatment helps maintain a healthier balance of bacteria and reduces inflammation and tissue breakdown.See study design
What are the potential side effects?
Potential side effects may include local irritation or discomfort in the genital area. There's also a risk for those susceptible to hormone-related conditions such as blood clots or hormone-sensitive cancers.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 6 and 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 and 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Atrophic
Secondary outcome measures
HIV-1 RNA levels in the genital tract
Immunoglobulin (Ig)A and IgG coated bacteria
Vaginal Microbiome
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Estradiol Vaginal InsertExperimental Treatment1 Intervention
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.
Group II: No treatmentActive Control1 Intervention
No intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Estradiol Vaginal Insert
2020
Completed Phase 4
~60
Find a Location
Who is running the clinical trial?
Novo Nordisk A/SIndustry Sponsor
1,520 Previous Clinical Trials
2,416,314 Total Patients Enrolled
Albert Einstein College of MedicineLead Sponsor
287 Previous Clinical Trials
11,857,157 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,692 Previous Clinical Trials
28,027,163 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have used any vaginal or vulvar products in the month before joining the study.You are currently experiencing unusual or unexplained bleeding from your genital area.You have taken antibiotics in the last 30 days.You have a serious illness or ongoing health condition that might make it difficult for you to follow the study requirements.You have had a heart attack or stroke in the past or currently have these conditions.You have had a bad reaction to vaginal estradiol in the past.You have been experiencing vaginal dryness, itching, irritation, soreness, or pain at least once a week in the past month. Additionally, you have experienced pain during sexual activity at least once.The doctor sees signs of thin, pale, and dry vaginal and vulvar surfaces during the examination.
Research Study Groups:
This trial has the following groups:- Group 1: Estradiol Vaginal Insert
- Group 2: No treatment
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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