A Randomized, Single Center Pilot Study Comparing Hyaluronic Acid to Vaginal Estrogen for Treatment of Genitourinary Syndrome of Menopause
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Change in VSQ Score
研究概览
简要总结
Non-hormonal alternatives for the treatment of genitourinary syndrome of menopause (GSM) are needed. In this proposed trial, patients who are diagnosed with GSM will be randomized to receive either a hyaluronic acid (HLA) vaginal insert or vaginal estrogen topical cream for 12 weeks. There will be a baseline visit and an 12 week follow up visit, at which points the patient will undergo a detailed history and physical examination including a pelvic exam, vaginal pH sampling, vaginal cell sample for microscopic analysis, and will fill out a vulvovaginal symptom questionnaire (VSQ). These study arms will be analyzed to assess the efficacy of HLA as compared to the gold standard of vaginal estrogen to treat GSM symptoms.
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
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal status as defined by amenorrhea for >12 months or history of bilateral salpingo-oophrectomy or if the patient has had a hysterectomy and menopausal symptoms for >1 year or FSH > 40
- •Symptoms of GSM
- •Negative Pap smear as per ASCCP guidelines
- •Capable of giving informed consent
- •Capable and willing to follow all study-relation procedures
排除标准
- •Use of any HRT (systemic or local) or raloxifene within six weeks of proposed start date
- •History of estrogen-sensitive tumor
- •Undiagnosed vaginal bleeding in the past 12 months
- •History of thromboembolic event
- •Currently have or have had liver problem
- •Bleeding disorder
- •Impaired mental status
- •Prior pelvic irradiation
- •Active vaginal infection
- •Any medical reason the investigator deems incompatible with treatment with vaginal estrogen
研究组 & 干预措施
Investigational
干预措施: Revaree (Device)
Standard of Care
干预措施: Estrace (Drug)
结局指标
主要结局
Change in VSQ Score
时间窗: Baseline, Week 12
The VSQ (Vulvovaginal Symptoms Questionnaire) is a 21-question survey developed in 2012 that specifically asks about GSM symptoms, their emotional impact, sexual impact, and life impact. Each question is scored from 0 (free of discomfort) to 3 (severe discomfort) The total score ranges from 0 (symptom-free in all areas) to 63 (severe discomfort in all areas) - the higher the score, the more severe the discomfort.
次要结局
- Change in Vaginal pH(Baseline, Week 12)
- Change in VMI(Baseline, Week 12)
- Change in VAS Score - Dyspareunia(Baseline, Week 12)