NCT00744276已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Multicenter Evaluation of the Use of Topically Administered Danazol Versus Placebo in Subjects With Pain Associated With Fibrocystic Breast Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 29
- 主要终点
- Subject reported breast pain as measured using a visual analog scale on the subject daily diary
研究概览
简要总结
The purpose of this study is to determine the safety of three doses of topically applied danazol compared to placebo in subjects with pain associated with fibrocystic breast disease and to determine the appropriate clinical dose for future studies.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Menstruating females at least 18 years of age
- •Has moderate to severe breast pain associated with cyclical fibrocystic breast disease
- •Is in good general health
排除标准
- •Pregnant within the past 6 months or lactating
- •History of malignancy or currently being treated for cancer of the breast or genital organs
- •Has taken within the past 3 months or is currently taking hormonal contraception
- •Has any condition for which an androgen or steroid is contraindicated
- •Has had breast implants or breast reduction surgery
研究组 & 干预措施
2
Active Comparator
干预措施: danazol (Drug)
3
Active Comparator
干预措施: danazol (Drug)
1
Active Comparator
干预措施: danazol (Drug)
4
Placebo Comparator
干预措施: Placebo (Drug)
5
Placebo Comparator
干预措施: Placebo (Drug)
6
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Subject reported breast pain as measured using a visual analog scale on the subject daily diary
时间窗: 2 cycles pretreatment plus 4 cycles on treatment
次要结局
- Physician assessment of breast nodularity at each treatment cycle visit(2 cycles pretreatment plus 4 cycles on treatment)
研究者
研究点 (29)
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