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临床试验/NCT00755963
NCT00755963已完成4 期

The Influence of Hormone Replacement Therapy on the Cerebral Serotonin-1A Receptor Distribution and Mood in Postmenopausal Women

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Serotonin-1A receptor binding potential

研究概览

简要总结

Menopausal and postmenopausal women compose almost 20% of the Austrian population. Two thirds of all austrian women suffering from depression or anxiety disorders are over 45 years old. The serotonergic system, partially regulated by the steroid hormones estrogen and progesterone, plays a major role in the pathogenesis and treatment of these illnesses. To examine the effect of the hormone replacement therapy on the serotonergic system, twenty-four postmenopausal women will be measured using positron emission tomography (PET). The volunteers will participate in two PET scans. The first PET scan will be performed right before the hormone treatment starts, the second PET scan about 8 weeks after daily treatment with (1) a combination of estrogen and progesterone or (2) estrogen and placebo. This imaging study hypothesizes that the expression of the main inhibiting serotonergic receptor (the serotonin-1A receptor) will be altered by the hormone therapy. The results of the study might lead to new strategies in the treatment of psychiatric illnesses during and after the menopausal transition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

1

Experimental

干预措施: estradiol valerate (Drug)

1

Experimental

干预措施: micronized progesterone (Drug)

2

Experimental

干预措施: estradiol valerate (Drug)

3

Placebo Comparator

Placebo

干预措施: placebo (Drug)

结局指标

主要结局

Serotonin-1A receptor binding potential

时间窗: 24 months

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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