Comparison of a Novel Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause: a Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- PROM: Quality of Life
研究概览
简要总结
The goal of this randomized controlled trial is to test the efficacy of StrataMGT in the management of Genitourinary Syndrome of Menopause (GSM) compared to estrogen therapy. The main question it aims to answer is:
- Will StrataMGT be non-inferior regarding patient quality of life compared to standard of care?
Participants will use either StrataMGT or estrogen vaginal cream to treat GSM for 3 consecutive months. After the baseline assessment, participants will be assessed monthly for quality of life, clinical signs, symptoms, pathology and adverse reactions.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Able to provide informed consent
- •Confirmed postmenopausal age
- •Diagnosed genitourinary syndrome of menopause
- •Access to a smartphone, tablet or computer, and to a functional email address.
排除标准
- •Contraindication for the use of estrogen therapy
- •Unable to provide informed consent
- •Patient unable to apply topical device
- •Allergy or intolerance to ingredients or excipients of the formulation of studied products
研究组 & 干预措施
StrataMGT
Participants will apply StrataMGT (silicone gel) 2-5 times daily (no limit in application times) to treat GSM for 3 months.
干预措施: StrataMGT (Device)
Estrace
Participants will receive Estrace vaginal cream (estrogen) to treat GSM for 3 months. Application will be 1 g daily for the first two weeks. Afterwards, a maintenance dosage of 1 g three times a week is applied.
干预措施: Estrace 0.01% Vaginal Cream (Drug)
结局指标
主要结局
PROM: Quality of Life
时间窗: 3 months
The improvement of patient quality of life will be assessed at baseline and during each monthly follow-up using the patient-rated Vulvar Disease Quality of Life (VQLI) Index questionnaire. Questions are rated on a numeric scale from 0 (not at all) - 3 (very much). This outcome is patient-rated, thus unblinded.
次要结局
- PROM: Symptoms(3 months)
- PROM: Treatment Adherence(3 months)
- Clinical signs(3 months)
- PROM: Dyspareunia(3 months)
- Adverse Reactions(3 months)
- Visual pathology(3 months)
- PROM: Product Rating(3 months)