A Randomized Pilot Study of Two New Drug Combinations Fot the Termination fo Early Pregnancy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- efficacy
研究概览
简要总结
In menstruation an effective shedding of the endometrial lining occurs. Both progesterone and estrogen levels fall sharply at this time. During medical abortion the endometrial shedding is sometimes ineffective causing an incomplete abortion which may cause prolonged bleeding or require surgical intervention. In medical abortion a progesterone antagonist is used as treatment but the estrogen levels are not targeted. The investigators wish to explore whether addition of letrozole or trilostane which target estrogen levels can lead to a more effective shedding of the endometrial lining.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy women aged 18-45 without any contraindication for treatment of any of the drugs involved in teh study
排除标准
- •Any ongoing medication or medical condition smoking >20 cigarettes per day BMI >30
研究组 & 干预措施
trilostane
patients will receive Day 1: Mifepristone 200 mg and Trilostane 120mg 1 tablet twice and Day 2 Trilostane 240mg twice. On Day 3 800 mcg misoprostol will be given vaginally.
干预措施: Trilostane (Drug)
Letrozole
Patients will receive on Day 1 Mifepristone 200mg and Letrozole 2,5mg 3 tablets and on Day 2 Letrozole 2,5mg 3 tablets. On day 3 800mcg of misoprostol will be given vaginally
干预措施: Letrozole (Drug)
结局指标
主要结局
efficacy
时间窗: 4 weeks
Evaluation of complete abortion by clinical judgement and ultrasonography
次要结局
- Acceptability(1 week, 2 weeks and 4 weeks)
研究者
Kristina Gemzell Danielsson
Professor
Karolinska Institutet