NCT00318500已完成2 期
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 75 mg and 150 mg Doses of ERB-041 on the Reduction of Symptoms Associated With Endometriosis During Treatment and Post Treatment in Reproductive-Aged Women
Wyeth is now a wholly owned subsidiary of Pfizer70 个研究点 分布在 2 个国家目标入组 150 人开始时间: 2006年5月1日最近更新:
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相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 70
- 主要终点
- severity scores for dysmenorrhea, pelvic pain and deep dyspareunia from baseline through 12 weeks of treatment using the B & B scale administered by the investigator
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of two doses of ERB-041 (75 mg and 150 mg) relative to placebo on the relief of endometriosis-related symptoms (dysmenorrhea, pelvic pain, and deep dyspareunia) in reproductive aged women.
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
- 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 the last 10 years
- •Sexually active, nonpregnant, nonlactating women (18-45 years) with regular menstrual cycles who are willing to use non-hormonal contraception
排除标准
- •Conditions requiring the use of chronic pain therapy
- •Prophylactic use of analgesics to avoid endometriosis-related pain
结局指标
主要结局
severity scores for dysmenorrhea, pelvic pain and deep dyspareunia from baseline through 12 weeks of treatment using the B & B scale administered by the investigator
次要结局
- change in health related quality of life questionnaires
- change in severity scores for pelvic tenderness and pelvic induration during 12 weeks of treatment
- change in rescue medication use
研究者
研究点 (70)
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