临床试验/NCT00758953

NCT00758953已完成2 期

Pain Associated With Endometriosis

Lumara Health, Inc.0 个研究点目标入组 66 人开始时间: 2007年2月最近更新: 2012年3月6日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Lumara Health, Inc.
入组人数: 66
主要终点: Pain associated with endometriosis

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study will evaluate the efficacy and safety of an investigational medication compared with placebo in the treatment of pain associated with endometriosis.

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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 50 Years（Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Menstruating female 18-50 years of age,
•Regular cycle length of 21 to 35 days with menstrual bleeding that typically lasts no more than 7 days,
•Has pain associated with endometriosis,
•Has a documented history consistent with endometriosis,

排除标准

•Is pregnant or lactating,
•Has a history of or has active thrombosis

研究组 & 干预措施

1

Experimental

干预措施: Danazol Once Weekly (Drug)

2

Experimental

干预措施: Danazol Twice Weekly (Drug)

3

Placebo Comparator

干预措施: Placebo Once Weekly (Drug)

4

Placebo Comparator

干预措施: Placebo Twice Weekly (Drug)

结局指标

主要结局

Pain associated with endometriosis

时间窗: 3 months of treatment

次要结局

未报告次要终点

研究者

发起方

Lumara Health, Inc.

申办方类型

Industry

责任方

Sponsor

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