Myo-inositol and Melatonin in Menopausal Transition. A Prospective, Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Normalizing irregular bleeding and anovulatory cycles in pre-menopausal women.
研究概览
简要总结
The purpose of this study is to determine whether myo-inositol and melatonin, or myo-inositol alone, or melatonin alone, are effective in normalizing irregular bleeding and anovulatory cycles in pre-menopausal women.
详细描述
Melatonin has produced a remarkable significant improvement of thyroid function, positive changes of gonadotropins towards reduced levels, and in some women a re-acquisition of normal menstrual cycle. Furthermore, an abrogation of menopause-related depression, amelioration of hot-flashes and improvement of quality and duration of sleep has been reported.
Myo-inositol is involved in several aspects of human reproduction. Elevated concentrations of myo-inositol in human follicular fluids appear to play a positive function in follicular maturity and provide a marker of good quality oocytes. Nevertheless its positive role in PCOS women is a consequence of a defect in the insulin signalling pathway (inositol-containing phosphoglycan mediators) that seems to be primarily implicated in the pathogenesis of insulin resistance
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
- 40 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •all pre-menopausal women with irregular cycles and bleedings
排除标准
- •pre-menopausal women who take hormonal drugs
结局指标
主要结局
Normalizing irregular bleeding and anovulatory cycles in pre-menopausal women.
时间窗: 12 months
次要结局
- Evaluation of metabolic markers (insulin, glucose, total cholesterol, HDL-cholesterol, triglycerides).(12 months)
- Serum assays of thyroid hormones.(12 months)
- Assays of gonadotropins and estradiol serum levels(12 months)
- Variation of blood pressure.(12 months)
- Variation of mood, hot flashes, quality of sleep.(12 months)
研究者
Rosario D'anna
Myo-inositol and melatonin in menopausal transition.
University of Messina