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

Brief Summary
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.
Brief Title
Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV
Central Contacts
Central Contact Role
Contact
Central Contact Phone
718-839-7885
Central Contact Email
kerry.murphy@einsteinmed.edu
Central Contact Role
Contact
Central Contact Phone
718-430-3240
Central Contact Email
marla.keller@einsteinmed.edu
Completion Date
Completion Date Type
Estimated
Conditions
MENOPAUSAL COMPLAINTS
VAGINAL ATROPHY
GENITOURINARY SYMPTOMS
HIV (HUMAN IMMUNODEFICIENCY VIRUS)
MENOPAUSE RELATED CONDITIONS
VAGINITIS
PERIMENOPAUSE
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
Inclusion 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)

Gender
Female
Gender Based
false
Keywords
Pain with sex
Vaginal dryness
Symptoms of menopause
HIV Infection
Menopause
Vaginal microbiome
Dysbiosis
Aging
Premature aging
Atrophic vaginitis
Genitourinary syndrome of menopause (GSM)
Symptoms of perimenopause
Healthy Volunteers
No
Last Update Submit Date
Maximum Age
70 Years
Minimum Age
40 Years
NCT Id
NCT07526948
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2026-17642
Overall Status
Not yet recruiting
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Vaginal Estradiol Versus Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms, Dysbiosis and Markers of Latency Reversal in Menopausal Women Living With HIV
Primary Outcomes
Outcome Description
Changes in the vaginal microbiome as defined by the change in alpha diversity from baseline to 16 weeks will be assessed. It is hypothesized that this may be a biomarker for improvement in vaginal health. Lower alpha diversity would indicate a favorable change in the microbiome.
Outcome Measure
Change in the vaginal microbiome (bacteria) as defined by the change in alpha diversity
Outcome Time Frame
From Baseline to 16 weeks
Secondary Ids
Secondary Id
R01AG102277
Secondary Outcomes
Outcome Description
Using a survey administered at each visit, participants will rate the severity of five vaginal (dryness, itching, irritation, soreness, and dyspareunia) and three urinary (frequency, urgency, recurrent UTIs) symptoms based on a four-point scale (0=none, 1=mild, 2=moderate, 3=severe). A composite GSM symptom index will be calculated as the mean severity of the corresponding symptoms at each visit. A higher score indicates increased severity of symptoms.

It is anticipated that both vaginal estradiol and the vaginal moisturizer will lead to improvement in the symptoms of the genitourinary syndrome of menopause.
Outcome Time Frame
From Baseline to 16 weeks
Outcome Measure
Change in genitourinary syndrome of menopause (GSM) symptoms as defined by the composite GSM symptom index
Start Date
Start Date Type
Estimated
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
70
Minimum Age Number (converted to Years and rounded down)
40
Investigators
Investigator Type
Principal Investigator
Investigator Name
Kerry Murphy
Investigator Email
kerry.murphy@einsteinmed.edu
Investigator Department
Medicine
Investigator Division
Infectious Diseases
Investigator Sponsor Organization
Einstein
Study Department
Medicine
Study Division
Infectious Diseases
Categories Mesh Debug
HIV/AIDS --- ACQUIRED IMMUNODEFICIENCY SYNDROME
HIV/AIDS --- HIV INFECTIONS
Infectious Disease --- HIV INFECTIONS
Aging --- AGING, PREMATURE
Blood Disorders --- BLOOD-BORNE INFECTIONS
HIV/AIDS --- BLOOD-BORNE INFECTIONS
Infectious Disease --- BLOOD-BORNE INFECTIONS
Hepatitis --- COMMUNICABLE DISEASES
HIV/AIDS --- COMMUNICABLE DISEASES
Infectious Disease --- COMMUNICABLE DISEASES
COVID-19 --- INFECTIONS
Infectious Disease --- INFECTIONS
HIV/AIDS --- SEXUALLY TRANSMITTED DISEASES, VIRAL
Infectious Disease --- SEXUALLY TRANSMITTED DISEASES, VIRAL
HIV/AIDS --- SEXUALLY TRANSMITTED DISEASES
Infectious Disease --- SEXUALLY TRANSMITTED DISEASES
Infectious Disease --- LENTIVIRUS INFECTIONS
Infectious Disease --- RETROVIRIDAE INFECTIONS
COVID-19 --- RNA VIRUS INFECTIONS
Infectious Disease --- RNA VIRUS INFECTIONS
COVID-19 --- VIRUS DISEASES
Hepatitis --- VIRUS DISEASES
Infectious Disease --- VIRUS DISEASES
Immune System --- IMMUNE SYSTEM DISEASES
MeSH Terms
ACQUIRED IMMUNODEFICIENCY SYNDROME
VAGINITIS
HIV INFECTIONS
DYSBIOSIS
AGING, PREMATURE
ATROPHIC VAGINITIS
BLOOD-BORNE INFECTIONS
COMMUNICABLE DISEASES
INFECTIONS
SEXUALLY TRANSMITTED DISEASES, VIRAL
SEXUALLY TRANSMITTED DISEASES
LENTIVIRUS INFECTIONS
RETROVIRIDAE INFECTIONS
RNA VIRUS INFECTIONS
VIRUS DISEASES
SLOW VIRUS DISEASES
GENITAL DISEASES
UROGENITAL DISEASES
IMMUNOLOGIC DEFICIENCY SYNDROMES
IMMUNE SYSTEM DISEASES
VAGINAL DISEASES
GENITAL DISEASES, FEMALE
FEMALE UROGENITAL DISEASES
FEMALE UROGENITAL DISEASES AND PREGNANCY COMPLICATIONS
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
SIGNS AND SYMPTOMS
ESTRADIOL
REPLENS
ESTRENES
ESTRANES
STEROIDS
FUSED-RING COMPOUNDS
POLYCYCLIC COMPOUNDS
ESTRADIOL CONGENERS
GONADAL STEROID HORMONES
GONADAL HORMONES
HORMONES
HORMONES, HORMONE SUBSTITUTES, AND HORMONE ANTAGONISTS