Vaginal Estradiol Versus Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms, Dysbiosis and Markers of Latency Reversal in Menopausal Women Living With HIV
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Change in the vaginal microbiome (bacteria) as defined by the change in alpha diversity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The pathologist assigning the vaginal maturation index (VMI) to the samples will be blinded to which group the participant sample is from.
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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)
干预措施: Vaginal moisturizer (Other)
Vaginal Estradiol, Participants Living With HIV
Participants living with HIV randomized to this arm will use vaginal estradiol tablets for the duration of the study (16 weeks)
干预措施: Vaginal estradiol tablets (Drug)
Vaginal Estradiol, Participants without HIV
Participants without HIV enrolled in the study will use vaginal estradiol tablets for the duration of the study (16 weeks).
A 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.
干预措施: Vaginal estradiol tablets (Drug)
结局指标
主要结局
Change in the vaginal microbiome (bacteria) as defined by the change in alpha diversity
时间窗: 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. Lower alpha diversity would indicate a favorable change in the microbiome.
次要结局
- 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)
- Change in genitourinary syndrome of menopause (GSM) symptoms as defined by the composite GSM symptom index(From Baseline to 16 weeks)
研究者
Kerry Murphy
Dr. Kerry Murphy
Albert Einstein College of Medicine