Compare the Effectiveness and Side Effects of Vaginal Estrogen and Platelet-rich Plasma Over Women With Genitourinary Syndrome of Menopause
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Female Sexual Function Index (FSFI)
研究概览
简要总结
The definition of Genitourinary Syndrome of Menopause (GSM) is the decline of estrogens during menopause results in symptoms and clinical signs from both systems. Estrogen and other hormones production decrease after menopause because the ovaries lose their effectiveness, leading to mucosal atrophy, reduced vaginal moisture, dysuria, urgency, recurrent infection, burning, pruritus and dyspareunia.
The treatment included vaginal estrogen supplement, vaginal hyaluronic acid supplement, vaginal laser, platelet rich plasma, etc. Observational cohort study will be used for study design, and questionnaire, pelvic examination, vaginal pap smear with maturation index (MI), vaginal pH, and other methods will be used for evaluation of the effectiveness and side effects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with menopause
- •Patients with symptoms of genitourinary syndrome of menopause
排除标准
- •Genitourinary bleeding or infection without definitive diagnosis
- •Coagulopathy
- •Allergy to medication or therapy related with the treatment
- •Chronic disease that might influence outcome
- •Using medication that might influence outcome in 30 days
- •Using hormone or steroid within 8 weeks
研究组 & 干预措施
Genital urinary symptoms of menopause
Menopause for one year, or age above 45 with symptoms of GSM
干预措施: Vaginal estrogen supplement (Drug)
Genital urinary symptoms of menopause
Menopause for one year, or age above 45 with symptoms of GSM
干预措施: Platelet-rich plasma injection (Procedure)
结局指标
主要结局
Female Sexual Function Index (FSFI)
时间窗: 2022/8/10-2024/2/28
A brief multidimensional scale for assessing sexual function in women.
Visual analogue scale (VAS)
时间窗: 2022/8/10-2024/2/28
Changes in GSM symptoms include vaginal dryness, dyspareunia, itching, burning, dysuria
Vaginal health index score (VHIS)
时间窗: 2022/8/10-2024/2/28
One of the most commonly used scores for the evaluation of vaginal elasticity, secretions, pH, the presence of petechiae on the epithelial mucosa, and hydration
次要结局
未报告次要终点
研究者
Hui-Hsuan Lau, MD
Doctor
Mackay Memorial Hospital