NCT04664985Unknown不适用
Evaluation of Mucogyne® Ovule in Vulvovaginal Dryness Management in Women Treated by Brachytherapy and/or Radiotherapy for Endometrial or Cervical Cancer.
Laboratoires IPRAD14 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年10月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 14
- 主要终点
- Vaginal Health Index (VHI) change from inclusion to end of study
研究概览
简要总结
Randomized, open-label, national (France), multicenter, prospective clinical study, to evaluate the superiority of Mucogyne® ovules over the control group on vaginal health (including hydration) in women treated by brachytherapy and/or radiotherapy for endometrial or cervical cancer.
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 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman over 18
- •hysterectomized patient with endometrial cancer (stage I, stage II and histological type I, without chemotherapy, with brachytherapy and/or radiotherapy) OR patient with cervical cancer (stage IA2 and IB1 with emboli or positive lymphadenopathy and IB2 stages with or without chemotherapy, with brachytherapy and / or radiotherapy)
- •Only for patients with cervical cancer, premenopausal and non-hysterectomized: patient on contraception at least one month before V0 and throughout the study
- •Only for patients with cervical cancer: complete remission
- •Patient capable of receiving and understanding information related to the study, giving informed written consent, and easily completing a quality of life questionnaire
- •Patient affiliated to the French social security system
排除标准
- •Patient with clinically observed vulvovaginal infections
- •Patient with endometrial cancer treated with chemotherapy
- •Patient already participating in another study
- •Patient under legal protection, or under guardianship or curatorship
- •Only for patients with cervical cancer: local treatment with estrogen
- •Only for patients with cervical cancer, premenopausal and non-hysterectomized: pregnancy (pregnancy test to be performed at V0)
结局指标
主要结局
Vaginal Health Index (VHI) change from inclusion to end of study
时间窗: 3 Months
Each parameter is evaluated from 1 (worst) to 5 (best/normal): * vaginal elasticity, * vaginal secretion volume, * vaginal pH, * epithelial mucous membrane integrity, * vaginal hydration/lubrication. The sum of points for each parameter gives the VHI, from 5 (worst) to 25 (best/normal)
次要结局
- Vaginal flora composition (Nugent score) evolution(3 Months)
- Vaginal mucosa scarring evolution(3 Months)
- Time to additional local treatment administration(3 Months)
- Complications and adverse events(3 Months)
- Patient Global Impression of Change (PGIC) on vaginal health(3 Months)
- Symptoms (pain, dyspareunia, vaginal pruritis, vulvovaginal dryness) evolution(3 Months)
- VHI change at each visit(3 Months)
- Patient satisfaction questionnaire at the end of study(3 Months)
研究者
研究点 (14)
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