Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Hysterectomy
研究概览
简要总结
The objective of this study is to assess the efficacy of an implantable etonogestrel device in reducing hysterectomy rate in patients with a failed endometrial ablation.
详细描述
The researchers aim to determine whether use of etonogestrel implant in patients with failed endometrial ablation significantly decreases hysterectomy rate. Changes in pelvic pain and vaginal bleeding will be assessed. Time to hysterectomy will be examined.
The researchers hypothesize that treatment of failed endometrial ablation with etonogestrel implant will decrease pelvic pain and vaginal bleeding resulting in a significantly decreased need for hysterectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Previous endometrial ablation
- •Pelvic pain and/or vaginal bleeding seeking treatment
排除标准
- •Previous or current VTE
- •Liver tumour, benign or malignant, or active liver disease
- •Undiagnosed abnormal genital bleeding
- •Known or suspected breast cancer
- •Uncontrolled hypertension
- •Allergy to component of etonogestrel implant
- •Lack of patient consent
研究组 & 干预措施
Etonogestrel implant
The participants will receive an etonogestrel 68mg implant
干预措施: Etonogestrel 68mg implant (Device)
结局指标
主要结局
Hysterectomy
时间窗: Occurrence of hysterectomy will be documented any time during the 3 year follow up period
occurrence of hysterectomy
次要结局
- Vaginal bleeding(PBAC score will be documented at baseline and 3, 6, 12, 18, 24, 30, and 36 months)
- Pelvic Pain(VAS will be documented at baseline and 3, 6, 12, 18, 24, 30, and 36 months)
- Time to Hysterectomy(Time of hysterectomy will be documented any time during the 3 year follow up period)
研究者
Sarah Smith
Obstetrician Gynecologist, Principal Investigator, Assistant Professor
Saskatchewan Health Authority - Regina Area