The Effect of Different Types of Progestin on Sleeping of Menopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Improving of sleeping quality (assessed by the PSQI score)
研究概览
简要总结
Investigators have found that sleeping disorder is an important problem in menopausal women.
There have been papers reporting the effect of hormonal therapy on sleeping, but fews have reported the effect of different progestogens on sleeping quality. There is a need for more in-depth study and more conclusive evidence about the progestins which have the most beneficial effects on sleeping disorders in menopausal women.
This study is going to collect the data from newly identified menopausal patients who are eligible for continuous estrogen-progestogen therapy for their climacteric treatment. The affects of the therapy will be monitored for 3 months.
详细描述
New patients who are eligible for hormonal therapy will be selected.
They will be allocated randomly into 2 different groups, each group being prescribed 1 of 2 regimens of hormonal therapy:
- 17 beta estradiol 1mg/day plus oral micronized progesterone 100mg/day
- 17 beta estradiol 1mg/day plus dydrogesterone 10mg/day Patients will have their sleeping quality accessed using the Pittsburgh sleep quality index(PSQI) at their 1st visit and once a month for 3 months. The first and third PSQI score will be analysed.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •new menopausal patients at Maharaj Nakorn Chiang Mai Hospital
- •suitable for estrogen plus progesterone treatment
排除标准
- •contraindication for hormone replacement therapy
- •recently used sleep enhancing medicine
- •recently used psychotic medicine
研究组 & 干预措施
micronized progesterone
1 mg 17 beta-estradiol plus 100 mg micronized progesterone taken orally once a day for 3 months.
干预措施: 1mg 17 beta-estradiol (Drug)
micronized progesterone
1 mg 17 beta-estradiol plus 100 mg micronized progesterone taken orally once a day for 3 months.
干预措施: micronized progesterone (Drug)
dydrogesterone
1mg 17 beta-estradiol plus 10 mg dydrogesterone taken orally once a day for 3 months.
干预措施: 1mg 17 beta-estradiol (Drug)
dydrogesterone
1mg 17 beta-estradiol plus 10 mg dydrogesterone taken orally once a day for 3 months.
干预措施: Dydrogesterone (Drug)
结局指标
主要结局
Improving of sleeping quality (assessed by the PSQI score)
时间窗: from March 2014 up to 15 months
次要结局
- The side effects comparing the 2 arms.(from March 2014 up to 15 months)
- The climacteric symptoms comparing the 2 arms.(from March 2014 up to 15 months)
研究者
Ekachai Leeangkoonsathian
MD
Chiang Mai University