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.
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)
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)
Parallel
Vaginal estradiol tablets
DrugUsing 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.
Vaginal moisturizer
Other interventionUsing 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.
Change in the vaginal microbiome (bacteria) as defined by the change in alpha diversity
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.
Change in genitourinary syndrome of menopause (GSM) symptoms as defined by the composite GSM symptom index
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.
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Albert Einstein College of Medicine
Lead sponsor
Yale University
Collaborator
Zymo Research
Collaborator
National Institute on Aging (NIA)
Collaborator
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