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

Официальное название

Vaginal Estradiol Versus Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms, Dysbiosis and Markers of Latency Reversal in Menopausal Women Living With HIV

Обзор

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.

Вмешательства

• Препарат 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.
• Другое 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.

Первичные конечные точки

• Change in the vaginal microbiome (bacteria) as defined by the change in alpha diversity [Срок оценки: From Baseline to 16 weeks]

Вторичные конечные точки (1)

• Change in genitourinary syndrome of menopause (GSM) symptoms as defined by the composite GSM symptom index [Срок оценки: From Baseline to 16 weeks]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Albert Einstein College of Medicine — The Bronx

Публикации

• Srinivasan S, Hua X, Wu MC, Proll S, Valint DJ, Reed SD, Guthrie KA, LaCroix AZ, Larson JC, Pepin R, Bhasin S, Raftery D, Fredricks DN, Mitchell CM. Impact of Topical Interventions on the Vaginal Microbiota and Metabolome in Postmenopausal Women: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e225032. doi: 10.1001/jamanetworkopen.2022.5032. PMID 35353163
• Murphy K, Keller MJ, Anastos K, Sinclair S, Devlin JC, Shi Q, Hoover DR, Starkman B, McGillick J, Mullis C, Minkoff H, Dominguez-Bello MG, Herold BC. Impact of reproductive aging on the vaginal microbiome and soluble immune mediators in women living with and at-risk for HIV infection. PLoS One. 2019 Apr 26;14(4):e0216049. doi: 10.1371/journal.pone.0216049. eCollection 2019. PMID 31026271
• Shen J, Song N, Williams CJ, Brown CJ, Yan Z, Xu C, Forney LJ. Effects of low dose estrogen therapy on the vaginal microbiomes of women with atrophic vaginitis. Sci Rep. 2016 Apr 22;6:24380. doi: 10.1038/srep24380. PMID 27103314
• Hummelen R, Macklaim JM, Bisanz JE, Hammond JA, McMillan A, Vongsa R, Koenig D, Gloor GB, Reid G. Vaginal microbiome and epithelial gene array in post-menopausal women with moderate to severe dryness. PLoS One. 2011;6(11):e26602. doi: 10.1371/journal.pone.0026602. Epub 2011 Nov 2. PMID 22073175
• Brotman RM, Shardell MD, Gajer P, Fadrosh D, Chang K, Silver MI, Viscidi RP, Burke AE, Ravel J, Gravitt PE. Association between the vaginal microbiota, menopause status, and signs of vulvovaginal atrophy. Menopause. 2018 Nov;25(11):1321-1330. doi: 10.1097/GME.0000000000001236. PMID 30358729
• Mitchell CM, Reed SD, Diem S, Larson JC, Newton KM, Ensrud KE, LaCroix AZ, Caan B, Guthrie KA. Efficacy of Vaginal Estradiol or Vaginal Moisturizer vs Placebo for Treating Postmenopausal Vulvovaginal Symptoms: A Randomized Clinical Trial. JAMA Intern Med. 2018 May 1;178(5):681-690. doi: 10.1001/jamainternmed.2018.0116. PMID 29554173
• Murphy K, Gromisch M, Connolly J, Wang T, McWalters J, Atrio J, Mahant AM, Gera S, Colanta A, Cajigas A, Kelly L, Estrella H, Gustafson D, Minkoff H, Anastos K, Keller MJ, Herold BC. Impact of Vaginal Estradiol on the Genitourinary Syndrome of Menopause, Vaginal Microbiome and Mucosal Immune Mediators in Women With HIV. Clin Infect Dis. 2026 Apr 30;82(4):e710-e719. doi: 10.1093/cid/ciaf669. PMID 41355723

Идентификаторы

NCT: NCT07526948 · 2026-17642 · R01AG102277

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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