NCT02497560终止2 期
A Randomized Double Blind Placebo-Controlled Study To Investigate The Effect Of A Natural Dietary Supplement On Peri-Menopausal Symptoms
Physician Recommended Nutriceuticals4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Hot flashes episodes
研究概览
简要总结
This is a randomized, masked, placebo controlled study to assess the effect on a nutritional dietary supplement on menopausal signs and symptoms in perimenopausal women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age group between 45 and 65 at the time of informed consent.
- •Physician diagnosis of menopause.
- •History of substantial hot flashes > 4 episodes /day for last 2 weeks.
- •Being post-menopausal with an intact uterus.
- •Subject has provided signed and dated written informed consent before admission to the study.
排除标准
- •Concurrent hot flash therapies (prescription medications including hormone replacement therapies, gabapentin or over the counter supplements), vaginal hormonal products (rings, creams, gels) or transdermal estrogen or estrogen/progestin products for 30 days before screening visit.
- •Women currently or previously on anticoagulants, Vitamin K antagonists like warfarin in the past 3 months, or expected to be on anticoagulants in the near future.
- •Women involved in other clinical studies within the last 30 days.
- •Any women who, in the opinion of the principal investigator, is at poor medical or psychiatric risk for the study.
结局指标
主要结局
Hot flashes episodes
时间窗: 12 weeks
Diary
次要结局
- Work productivity(12 weeks)
- Quality of Life(12 weeks)
研究者
研究点 (4)
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