A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study of the Effect of ERB-041 in the Reduction of Symptoms Associated With Endometriosis in Reproductive-Age Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 46
- 主要终点
- To assess the effects and to compare the safety profile of an investigational
研究概览
简要总结
The purpose of this investigational study is to determine if a study medication is safe and effective in reducing the symptoms associated with endometriosis; if the study medication reduces the need for pain medication for endometriosis symptoms; and if the study medication improves a participant's ability to carry out daily activities. Qualified participants will receive no cost treatment, which may include study-related examinations, diagnostic procedures including a Pap smear, laboratory testing, and a mammogram (aged 40-45). Qualified participants will also receive study medication at no cost. As a participant, the study volunteer may also experience the satisfaction of knowing she is helping the advancement of women's health care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
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
- •Surgical diagnosis of endometriosis within 5 years
- •Not pregnant and not lactating
- •Willing to use non-hormonal contraception, history of regular menstrual cycles
排除标准
- •Hysterectomy, surgical treatment for endometriosis within 3 months
- •Certain medications for the treatment of endometriosis
- •Previous history of a malignancy
- •Abnormalities on physical or gyn exams and abnormal lab tests
结局指标
主要结局
To assess the effects and to compare the safety profile of an investigational
medication on the relief of endometriosis-related symptoms.
次要结局
- Clinical and subject assessment of symptoms related to endometriosis and the
- use of analgesia to relieve symptoms.