NCT01300078Unknown1 期
A Phase 1 Open Label, Randomized Clinical Trial Assessing Safety of MF101 for Hot Flushes and Menopausal Symptoms in Postmenopausal Women
Bionovo4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Evaluate the safety of MF101, 10 g/day and 15 g/day
研究概览
简要总结
This Phase 1, open label, randomized clinical trial will enroll 40 generally healthy, postmenopausal women aged 40-65 years old. Women will be randomized to one of two oral doses of MF101 for 4 weeks. Participants will be recruited at 3 clinical sites in the United States.
详细描述
MF101 is an oral, non-hormonal, botanical agent being investigated for the treatment of menopausal hot flashes.
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
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MF101 10 grams/day
Experimental
干预措施: MF101 (Drug)
MF101 15 grams/day
Experimental
干预措施: MF101 (Drug)
结局指标
主要结局
Evaluate the safety of MF101, 10 g/day and 15 g/day
时间窗: Randomization to 4 weeks
New or worsening abnormalities on breast, physical and general exams, laboratory measures, transvaginal ultrasound, abnormal uterine bleeding, adverse events and serious adverse events.
次要结局
- Compare the safety of MF101 10g/day and 15 g/day(Randomization to 4 Weeks)
研究者
研究点 (4)
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