NCT00066144已完成2 期
Black Cohosh and Red Clover Efficacy for the Relief of Menopausal Symptoms
National Center for Complementary and Integrative Health (NCCIH)2 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2003年4月最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
研究概览
简要总结
This Phase II study, a follow-up to a Phase I trial in normal volunteers, will determine the efficacy of black cohosh and red clover for the relief of menopausal symptoms. It will also assess the safety of chronic dosing (1 year) by evaluating uterine (endometrial biopsies), breast (mammography), and hematology parameters (CBC and chemistry lab values) at baseline and 1 year.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Menopausal women with intact uterus
- •Must be experiencing hot flashes
- •No menstrual periods for at least 6 months and no longer than 3 years
- •Non-smoker
- •Must have intact uterus (no hysterectomy)
排除标准
- •Contraindications for hormone replacement therapy
- •Diabetes mellitus
- •Pregnancy or breast-feeding
- •Obese (BMI >35 excluded)
- •History of endometrial hyperplasia/neoplasia/malignancy
- •History of breast or reproductive cancer
- •History of severe recurrent depression, or severe psychiatric disturbance
- •History of stroke/CVA, severe varicose veins, sickle cell anemia, myocardial infarction (heart attack), or arrhythmia (rhythm disturbance of the heart)
- •History of abnormal vaginal bleeding of unknown cause
- •Untreated or uncontrolled high blood pressure/hypertension
- •Use of any medication or supplement containing estrogen, progestin, SERM, St. John's Wort, bisphosphonates, or phytoestrogens
- •History of hormone-associated migraines
- •History of deep vein thrombosis (blood clots), thrombophlebitis, or thromboembolic disorders
- •Participation in a clinical trial within 30 days
- •Abnormal endometrial biopsy or mammogram
- •Abnormal transvaginal ultrasound defined as >7mm thickness
研究者
研究点 (2)
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