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临床试验/NCT04517370
NCT04517370已完成不适用

CO2 Laser Therapy for the Treatment of GSM in Patients With Breast Cancer A Comparative, Randomized, Controlled Trial

Hadassah Medical Organization2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
Change in dryness

研究概览

简要总结

Given the need for an effective, non-hormonal treatment for Genitourinary syndrome of menopause GSM) symptoms in breast cancer survivors, the reported efficacy of fractional CO2 laser as such a treatment in retrospective studies, the study aims to evaluate the efficacy of CO2 laser for the treatment of GSM in breast cancer patients, in a prospective, randomized, blinded, placebo-controlled trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in dryness

时间窗: Follow up after 3 treatments and at 1 month, 3 months and 6 months after last treatment.

Change in VAS before and after completion of treatment for dryness

Change in dyspareunia

时间窗: Follow up after 3 treatments and at 1 month, 3 months and 6 months after last treatment.

Change in VAS before and after completion of treatment for dyspareunia

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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