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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 and 12 weeks for reporting.

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 more

Trial 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SIndustry Sponsor

1,513 Previous Clinical Trials

2,414,978 Total Patients Enrolled

Albert Einstein College of MedicineLead Sponsor

286 Previous Clinical Trials

11,856,930 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,668 Previous Clinical Trials

28,005,013 Total Patients Enrolled

Media Library

Estradiol Vaginal Insert (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04079218 — Phase 4

HIV/AIDS Research Study Groups: Estradiol Vaginal Insert, No treatment

HIV/AIDS Clinical Trial 2023: Estradiol Vaginal Insert Highlights & Side Effects. Trial Name: NCT04079218 — Phase 4

Estradiol Vaginal Insert (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04079218 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate size of the population involved in this research initiative?

"Affirmative. As per the information on clinicaltrials.gov, this medical experiment is presently recruiting volunteers. It was first posted on September 1st 2020 and has been updated as recently as November 3rd 2022. For now, 50 participants are needed at a single location for this endeavour to be successful."

Answered by AI

Is this trial open to individuals under the age of 55?

"This study is open to patients between the age of 45 and 70. For those younger than 18, there are 202 separate trials available; conversely 883 studies exist for older participants who exceed 65 years old."

Answered by AI

Are there any slots available for participants of this research project?

"According to information published on clinicaltrials.gov, this study is still recruiting patients. It was first announced in September 2020 and had its most recent edit occur in November 2022."

Answered by AI

Could I be approved to join this research effort?

"This investigation is seeking 50 volunteers with atrophic vaginitis aged 45-70. To qualify, candidates must demonstrate signs of atrophy on physical examination (including thin, pallid and arid vaginal and vulvar surfaces), forswear the use of products other than a vaginal estradiol tablet during the trial period, be free from HIV infection, display symptomatic vaginal atrophy in the past 30 days (defined as one or more moderate to severe intensity symptoms such as dryness, itching/irritation/soreness/pain) OR pain associated with sexual activity at least once per week."

Answered by AI

What ailments does Estradiol Vaginal Insert address?

"Estradiol Vaginal Insert is mainly used to alleviate a lack of menstrual cycles in the prior 6 months, but also has applications for hypoestrogenism, vasomotor symptoms linked with menopause and breast issues."

Answered by AI