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临床试验/NCT06324851
NCT06324851已完成4 期

The Use of Drospirenone/Estetrol, Nomegestrol Acetate/Estradiol and Ethinylestradiol/Dienogest in Random Start Rapid Preparation of Endometrium Before Office Hysteroscopic Polypectomies: a Multicenter, Prospective, Randomized Study

University of Palermo2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
150
试验地点
2
主要终点
Quality of endometrial preparation

研究概览

简要总结

The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of Drospirenone/Estetrol or Nomegestrol Acetate/Estradiol or Ethinylestradiol/Dienogest, in rapid preparation of endometrium for hysteroscopic polypectomy.

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

性别
Female
接受健康志愿者

入选标准

  • Patients with endometrial polyps.

排除标准

  • Patients with other endometrial pathologies.

研究组 & 干预措施

Drospirenone/Estetrol

Experimental

Patients with endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Drospirenone/Estetrol at any time of the menstrual cycle

干预措施: Drospirenone / Estetrol (Drug)

Nomegestrol Acetate/Estradiol

Experimental

Patients with endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Nomegestrol Acetate/Estradiol at any time of the menstrual cycle

干预措施: Nomegestrol Acetate / Estradiol (Drug)

Ethinylestradiol/Dienogest

Experimental

Patients with endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Ethinylestradiol/Dienogest at any time of the menstrual cycle

干预措施: Ethinylestradiol / Dienogest (Drug)

结局指标

主要结局

Quality of endometrial preparation

时间窗: 14th day of treatment

Quality of endometrial preparation assessed visually intraoperatively by the surgeon using a visual analog scale from 0 to 5

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Etrusco

M.D.

University of Palermo

研究点 (2)

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