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Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV

NCT07526948

Not Yet RecruitingPhase 4

Sponsor: Albert Einstein College of Medicine

Conditions: Menopausal Complaints, Vaginal Atrophy, Genitourinary Symptoms, HIV (Human Immunodeficiency Virus), Menopause Related Conditions

Interventions: Vaginal estradiol tablets, Vaginal moisturizer

Countries: United States

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.

Eligibility overview

Sex: FEMALE

Age: 40 Years to 70 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* female
* at least 40 years old
* menopausal (no menses in 12 months) within 2 years of last menstrual period or perimenopausal in the late menopausal transition, defined as an interval of amenorrhea greater than or equal to 60 days
* have symptoms of the genitourinary syndrome of menopause (GSM) which developed within the prior 2 years. Symptoms of GSM include vaginal symptoms including dryness, soreness, itching, irritation and dyspareunia and/or urinary symptoms including urgency, frequency and recurrent urinary tract infections (UTIs)

Exclusion Criteria:

* Unexplained or unevaluated abnormal genital bleeding
* Current or suspected pregnancy
* Desired pregnancy
* If less than 55 years old, have had a hysterectomy and have at least one ovary (as menopause cannot be determined in this case by amenorrhea alone)
* Pelvic or vaginal surgery in the prior 60 days
* Used systemic reproductive hormones in the last 2 months
* Used antibiotics in the last 30 days
* Used immunosuppressive medications in the prior 60 days including biologics, chemotherapeutics or post transplant immunosuppressive medications
* Used any vaginal or vulvar preparations in the last month
* Current active vaginal infection diagnosed at study entry
* Any serious disease or condition that may interfere with study compliance
* Current or previous history of breast cancer or estrogen dependent cancer (e.g., ovarian, endometrial)
* Current or previous history of deep vein thrombosis or pulmonary embolism
* Current or previous history of myocardial infarction or stroke
* Known clotting disorder including Protein C, Protein S and antithrombin deficiency, Factor V Leiden or prothrombin mutations
* Known severe liver disease including cirrhosis or active Hepatitis B
* Known allergic reaction to Vagifem (estradiol vaginal tablet) or Replens

Locations (1)

The Bronx, New York, United States