A Randomized Controlled Trial Comparing the Efficacy of Topical Vaginal Estrogen Versus Topical Vaginal Estrogen Plus Via, a Hyaluronic Acid-Based Vaginal Moisturizer, in the Treatment of Genitourinary Syndrome of Menopause
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 196
- 试验地点
- 2
- 主要终点
- Percent change in vulvovaginal symptom questionnaire (VSQ) score
研究概览
简要总结
This study aims to evaluate whether the administration of vaginal estrogen along with Via, a hyaluronic acid-based vaginal moisturizer, offers superior relief from symptoms of genitourinary syndrome of menopause (GSM) in the urogynecologic patient population, compared to administration of vaginal estrogen alone.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal (last menstrual period at least 12 months ago).
- •Aged 45 years or older and have symptoms of Genitourinary Syndrome of Menopause (GSM).
- •Have never tried vaginal estrogen therapy, or have tried vaginal estrogen therapy, but have not used vaginal estrogen and/or hyaluronic acid products for management of GSM symptoms within the last 3 months.
- •Capable of signing informed consent.
- •Capable and willing to follow all study-relation visits.
排除标准
- •Subjects currently diagnosed with or undergoing treatment for hormone-sensitive disease (e.g. breast cancer)
- •Subjects currently using systemic hormone replacement therapy
- •Subjects currently using estrogen hormonal therapies or hormone modulators (aromatase inhibitors or selective estrogen receptor modulators)
研究组 & 干预措施
Vaginal Estrogen Alone
Participants will administer vaginal estrogen tablets nightly for 2 weeks, then twice weekly for 14 weeks.
干预措施: Vaginal estrogen tablet (Drug)
Vaginal Estrogen + Hyaluronic acid (HLA)
Participants will administer vaginal estrogen tablets nightly for 2 weeks, then twice weekly for 14 weeks. Participants will concomitantly apply Via (Hyaluronic acid) nightly for 16 weeks.
干预措施: Vaginal estrogen tablet (Drug)
Vaginal Estrogen + Hyaluronic acid (HLA)
Participants will administer vaginal estrogen tablets nightly for 2 weeks, then twice weekly for 14 weeks. Participants will concomitantly apply Via (Hyaluronic acid) nightly for 16 weeks.
干预措施: Via Solv Wellness (Hyaluronic Acid Therapy) (Device)
结局指标
主要结局
Percent change in vulvovaginal symptom questionnaire (VSQ) score
时间窗: Baseline, Week 16
The VSQ is a 21-item survey designed to measure vaginal symptoms, emotions, life impact due to vulvovaginal symptoms, and sexual impact of vulvovaginal symptoms. The scores range from 0 - 20 with the higher score meaning greater impact from vulvovaginal symptoms.
次要结局
- Percent change in vaginal pH(Baseline, Week 16)
- Change in vaginal maturation index (VMI)(Baseline, Week 16)
- Number of adverse events related to treatment(Week 16)