NCT00288691已完成2 期
A Multi-center, Double-blind, Placebo-controlled, Randomized, Parallel Group Study to Evaluate the Effects of Different Doses of SH T 00127B in Women With Treatment-resistant Menorrhagia Aged 30 to 55 Years After Daily Oral Administration of Multiple Doses for 35 up to 50 Days
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 26
- 主要终点
- Individual relative change in uterine bleeding scores by PBAC
研究概览
简要总结
The aim of this study is to explore effects of the investigational product for the treatment of treatment-resistant menorrhagia without organic cause.
详细描述
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with treatment-resistant menorrhagia scheduled for hysterectomy.
排除标准
- •Organic causes of menorrhagia
- •Current hormone treatment
研究组 & 干预措施
Arm 4
Placebo Comparator
干预措施: Placebo (Drug)
Arm 1
Experimental
干预措施: Asoprisnil (BAY86-5294) (Drug)
Arm 2
Experimental
干预措施: Asoprisnil (BAY86-5294) (Drug)
Arm 3
Experimental
干预措施: Asoprisnil (BAY86-5294) (Drug)
结局指标
主要结局
Individual relative change in uterine bleeding scores by PBAC
时间窗: Pretreatment cycle treatment phase
次要结局
- Endometrial thickness(End of treatment)
- Adverse events collection(Whole treatment period)
- Bleeding pattern(Treatment period)
- Endometrial histology incl. immunohistochemical evaluations(End of treatment)
研究者
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