{"type":"trials","record":{"id":21735,"source_id":"clinicaltrials-gov","external_id":"NCT07526948","title":"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.","overall_status":"Not Yet Recruiting","phases":["PHASE4"],"study_type":"INTERVENTIONAL","sponsor":"Albert Einstein College of Medicine","enrollment":62,"countries":["United States"],"start_date":"2026-09-01","completion_date":"2029-10-14","last_update_date":"2026-07-28","source_url":"https://clinicaltrials.gov/study/NCT07526948","editorial_summary":"A registered PHASE4 study indexed because it matched monitored longevity research terms. Registry status: Not Yet Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-24T01:17:09.678176+00:00","last_seen_at":"2026-09-25T06:05:41.111+00:00","metadata":{"sex":"FEMALE","acronym":null,"age_range":"40 Years to 70 Years","comparator":"Vaginal Estradiol, Participants without HIV; Vaginal Moisturizer, Participants Living with HIV","organization":"Albert Einstein College of Medicine","interventions":["Vaginal estradiol tablets","Vaginal moisturizer"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change in the vaginal microbiome (bacteria) as defined by the change in alpha diversity — From Baseline to 16 weeks","Change in genitourinary syndrome of menopause (GSM) symptoms as defined by the composite GSM symptom index — From Basel…"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Menopausal Complaints","Vaginal Atrophy","Genitourinary Symptoms","HIV (Human Immunodeficiency Virus)","Menopause Related Conditions","Vaginitis","Perimenopause","Vaginal estradiol tablets","Vaginal moisturizer"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: microbiome.","quality_checked_at":"2026-09-25T06:05:45.671606+00:00","duplicate_cluster_key":"id:nct07526948","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-09-01 to 2029-10-14","comparator":"Vaginal Estradiol, Participants without HIV; Vaginal Moisturizer, Participants Living with HIV","confidence":"structured-source","population":"FEMALE · 40 Years to 70 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:05:41.117Z","intervention":["Vaginal estradiol tablets","Vaginal moisturizer"],"participants":62,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · NONE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE4","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Change in the vaginal microbiome (bacteria) as defined by the change in alpha diversity — From Baseline to 16 weeks","Change in genitourinary syndrome of menopause (GSM) symptoms as defined by the composite GSM symptom index — From Basel…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"microbiome-dysbiosis","is_published":true,"match_reasons":["Title contains controlled term: microbiome.","Abstract contains controlled term: microbiome.","Title supplies longevity context: aging.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Microbiome and dysbiosis","slug":"microbiome-dysbiosis"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/21735","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}