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临床试验/NCT00081952
NCT00081952已完成1 期

Amino Acid Therapy for Hot Flashes/Postmenopausal Women

National Center for Complementary and Integrative Health (NCCIH)2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2003年10月1日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
15
试验地点
2

研究概览

简要总结

The purpose of this study is to determine the safety, tolerability, and effectiveness of the amino acid L-isoleucine in the treatment of hot flashes in postmenopausal women.

详细描述

Hot flashes affect approximately 75% of postmenopausal women. Although hormone replacement therapy (HRT) is highly effective in reducing hot flashes, long-term HRT is associated with increased rates of breast cancer and heart disease. Safe, effective, and well-tolerated hot flash therapies are needed. The amino acids L-methionine and L-isoleucine have produced reductions in hot flash frequency. However, long-term L-methionine therapy may increase cardiovascular risks. This study will evaluate the short-term effects of L-isoleucine therapy. Data from this study will be used to conduct long-term studies in the future.

Participants in this study will be randomly assigned to receive one of two different L-isoleucine doses for 2 weeks. Clinic visits will be made at baseline, Week 1, and Week 10. Participants will record the frequency and severity of their hot flashes in a diary.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment

入排标准

性别
Female
接受健康志愿者

入选标准

  • Postmenopausal
  • Experience over 5 hot flashes per day

排除标准

  • Hormone Replacement Therapy (HRT) in the past 2 months

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (2)

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