[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633458":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":38,"centralContacts":42,"locations":52,"responsibleParty":67,"collaborators":70,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":46,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":46,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":102,"overallStatus":115,"whyStopped":46,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Albert Einstein College of Medicine","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Vaginal Estradiol, Participants Living With HIV","EXPERIMENTAL","Participants living with HIV randomized to this arm will use vaginal estradiol tablets for the duration of the study (16 weeks)",[13],"Drug: Vaginal estradiol tablets",{"label":15,"type":16,"description":17,"interventionNames":18},"Vaginal Estradiol, Participants without HIV","ACTIVE_COMPARATOR","Participants without HIV enrolled in the study will use vaginal estradiol tablets for the duration of the study (16 weeks).\n\nA 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.",[13],{"label":20,"type":16,"description":21,"interventionNames":22},"Vaginal Moisturizer, Participants Living with HIV","Participants living with HIV randomized to this group will use vaginal moisturizer for the duration of the study (16 weeks)",[23],"Other: Vaginal moisturizer",[25,32],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Vaginal estradiol tablets","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.",[9,15],[31],"Vagifem",{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Vaginal 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.",[20],[37],"Replens",[39],{"name":40,"affiliation":5,"role":41},"Kerry J Murphy, MD","PRINCIPAL_INVESTIGATOR",[43,48],{"name":40,"role":44,"phone":45,"phoneExt":46,"email":47},"CONTACT","718-839-7885",null,"kerry.murphy@einsteinmed.edu",{"name":49,"role":44,"phone":50,"phoneExt":46,"email":51},"Marla J Keller, MD","718-430-3240","marla.keller@einsteinmed.edu",[53],{"facility":5,"status":46,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"The Bronx","New York","10461","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-73.86641,40.84985,{"lat":63,"lon":62},[66],{"name":40,"role":44,"phone":45,"phoneExt":46,"email":47},{"type":41,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":46,"oldOrganization":46},"Kerry Murphy","Dr. Kerry Murphy",[71,73],{"name":72,"class":6},"Yale University",{"name":74,"class":75},"Zymo Research","UNKNOWN","100633458","phase-4-vaginal-estradiol-vs-moisturizer-to-improve-postmenopausal-vaginal-aging-symptoms-and-the-microbiome-in-women-living-with-hiv-100633458",false,"NCT07526948","Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV","Vaginal Estradiol Versus Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms, Dysbiosis and Markers of Latency Reversal in Menopausal Women Living With HIV","Inclusion Criteria:\n\n* female\n* at least 40 years old\n* 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\n* 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\u002For urinary symptoms including urgency, frequency and recurrent urinary tract infections (UTIs)\n\nExclusion Criteria:\n\n* Unexplained or unevaluated abnormal genital bleeding\n* Current or suspected pregnancy\n* Desired pregnancy\n* 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)\n* Pelvic or vaginal surgery in the prior 60 days\n* Used systemic reproductive hormones in the last 2 months\n* Used antibiotics in the last 30 days\n* Used immunosuppressive medications in the prior 60 days including biologics, chemotherapeutics or post transplant immunosuppressive medications\n* Used any vaginal or vulvar preparations in the last month\n* Current active vaginal infection diagnosed at study entry\n* Any serious disease or condition that may interfere with study compliance\n* Current or previous history of breast cancer or estrogen dependent cancer (e.g., ovarian, endometrial)\n* Current or previous history of deep vein thrombosis or pulmonary embolism\n* Current or previous history of myocardial infarction or stroke\n* Known clotting disorder including Protein C, Protein S and antithrombin deficiency, Factor V Leiden or prothrombin mutations\n* Known severe liver disease including cirrhosis or active Hepatitis B\n* Known allergic reaction to Vagifem (estradiol vaginal tablet) or Replens",true,"FEMALE","40 Years","70 Years",{"count":88,"type":89},62,"ESTIMATED","INTERVENTIONAL",[92],"PHASE4","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.",[95,96,97,98,99,100,101],"Menopausal Complaints","Vaginal Atrophy","Genitourinary Symptoms","HIV (Human Immunodeficiency Virus)","Menopause Related Conditions","Vaginitis","Perimenopause",[103,104,105,106,107,108,109,110,111,112,113,114],"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","NOT_YET_RECRUITING","2026-04-08",{"date":118,"type":119},"2026-04-14","ACTUAL",{"date":121,"type":89},"2026-06-01",{"date":123,"type":89},"2031-06-30",{"name":5,"class":6},1]