临床试验/NCT01674426

NCT01674426已完成不适用

Pathogenesis of Functional Hypothalamic Amenorrhea

University of Pittsburgh2 个研究点分布在 1 个国家目标入组 17 人开始时间: 1997年11月最近更新: 2017年7月2日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: University of Pittsburgh
入组人数: 17
试验地点: 2
主要终点: ovarian function

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a randomized pilot study of the use of cognitive behavior therapy versus observation to treat functional hypothalamic amenorrhea, often termed stress-induced anovulation.

详细描述

The study enrollment was completed in 2003. The study results are being analyzed.

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: 18 Years 至 35 Years（Adult）
性别: Female
接受健康志愿者: 否

入选标准

•women with functional hypothalamic amenorrhea
•day awake / night asleep schedule

排除标准

•eating disorders, depression, excessive exercise or any other cause of amenorrhea and anovulation other than functional hypothalamic amenorrhea
•weight loss greater than 10 pounds when amenorrhea developed
•running more than 10 miles per week or exercising more than 10 hours per week

结局指标

主要结局

ovarian function

时间窗: Change before and after 20 weeks of CBT or observation

The change in ovarian function was assessed by comparing ovarian function before and after 20 weeks of CBT or observation using menses and serial estradiol and progesterone level as indices of ovarian function

次要结局

metabolism(Change before and after 20 weeks of CBT or observation)

研究者

发起方

University of Pittsburgh

申办方类型

Other

责任方

Principal Investigator

主要研究者

Sarah Berga

Professor

University of Pittsburgh

研究点 (2)

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