NCT01105793已完成2 期
An Open-Label, MultiCenter Evaluation of the Use of Topically Administered FP1198 in Subjects With Pain Associated With Cyclic Mastalgia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 8
- 主要终点
- Reduction in breast pain
研究概览
简要总结
The purpose of this study is to determine the safety of topical FP1198 for the treatment of moderate to severe cyclic breast pain (cyclic mastalgia) and to examine the clinical activity of FP1198.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •menstruating females at least 18 years of age
- •BMI less than 30
- •moderate to severe breast pain associated with the menstrual cycle
- •in good general health
排除标准
- •pregnant within the last 6 months
- •has taken in the last 3 months or currently taking hormonal contraception
- •history of malignancy or currently being treated for cancer of the breast or genital organs
- •has had breast implants or breast reduction surgery
结局指标
主要结局
Reduction in breast pain
时间窗: six months
次要结局
未报告次要终点
研究者
研究点 (8)
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