Menopausal Complaints, Vaginal Atrophy, Genitourinary Symptoms, HIV (Human Immunodeficiency Virus), Menopause Related Conditions, Vaginitis, Perimenopause
Conditions
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
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.
Interventions
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 16 weeks.
OTHERVaginal moisturizer
Using a pre-loaded single-use plastic applicator, participants will insert one vaginal moisturizer applicator intravaginally twice weekly for the duration of the study for a total of 12 weeks.
Sponsors
Albert Einstein College of Medicine
Yale University
Zymo Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The pathologist assigning the vaginal maturation index (VMI) to the samples will be blinded to which group the participant sample is from.
Intervention model description
Participants living with HIV will be randomly assigned to receive treatment with estradiol vaginal tablets or to vaginal moisturizer (Replens). Participants without HIV will receive treatment with estradiol vaginal tablets.
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the vaginal microbiome (bacteria) as defined by the change in alpha diversity | From Baseline to 16 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the symptoms of the genitourinary syndrome of menopause as defined by change in the composite vaginal symptom index (VSI) | From Baseline to 16 weeks | Using a survey administered at each visit, participant symptoms will be assessed over the course of the study. It is anticipated that both the vaginal estradiol and the vaginal moisturizer will lead to improvement in the symptoms of the genitourinary syndrome of menopause. |
Countries
United States
Contacts
CONTACTKerry J Murphy, MD
CONTACTMarla J Keller, MD
PRINCIPAL_INVESTIGATORKerry J Murphy, MD
Albert Einstein College of Medicine
Outcome results
None listed