Vaginal Estradiol vs Moisturizer for Menopause in Women with HIV

Overseen By Marla J Keller, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Albert Einstein College of Medicine

Must not be taking: Antibiotics, Immunosuppressives, Hormones, others

Disqualifiers: Breast cancer, Stroke, Clotting disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a research study about the effects of vaginal estradiol compared to moisturizer on vaginal symptoms of menopause and the microbiome in women with HIV. This research study aims to understand how vaginal products affect the aging of the female genital tract in women living with HIV who are menopausal or perimenopausal and have vaginal or urinary symptoms. There is a comparison group of women who are living without HIV. Participants with HIV and vaginal or urinary menopausal symptoms (e.g., dryness, irritation, soreness, itching, pain with sex, dysuria, urgency, or frequent urinary tract infections) will be asked to apply vaginal estradiol or a vaginal moisturizer (Replens). Participants who have vaginal or urinary menopausal symptoms and do not have HIV will receive vaginal estradiol.

Who Is on the Research Team?

Kerry J Murphy, MD

Principal Investigator

Albert Einstein College of Medicine

Are You a Good Fit for This Trial?

Inclusion Criteria

I am female.

I have had menopause-related vaginal or urinary symptoms start within the last 2 years.

I have not had a period for at least 12 months or my periods are very irregular.

Exclusion Criteria

I do not have any serious health problems that would prevent me from following the study plan.

I have had pelvic or vaginal surgery in the last 60 days.

I have used hormone medications in the past 2 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply vaginal estradiol or a vaginal moisturizer for the duration of the study

16 weeks

Visits at baseline and regular intervals

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vaginal Estradiol
• Vaginal Moisturizer

How Is the Trial Designed?

Group I: Vaginal Estradiol, Participants Living With HIV Experimental Treatment 1 Intervention

Participants living with HIV randomized to this arm will use vaginal estradiol tablets for the duration of the study (16 weeks)

Group II: Vaginal Estradiol, Participants without HIV Active Control 1 Intervention

Participants without HIV enrolled in the study will use vaginal estradiol tablets for the duration of the study (16 weeks). A control group of women without HIV with GSM (n=12) will be treated with vaginal estradiol for 16 weeks but will not be randomized to moisturizer as topical estrogen has already been shown (and is FDA approved) to improve symptoms and the vaginal microbiome in women without HIV infection.

Group III: Vaginal Moisturizer, Participants Living with HIV Active Control 1 Intervention

Participants living with HIV randomized to this group will use vaginal moisturizer for the duration of the study (16 weeks)

Who Is Running the Clinical Trial?

Albert Einstein College of Medicine

Lead Sponsor

Trials

302

Recruited

11,690,000+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Zymo Research

Collaborator

Trials

1

Recruited

480+