The Prospective, Blind, Randomized, Placebo-controlled, 4 Months Study of Efficacy of Melsmon® for Correction of Insomnia and Other Climacteric Symptoms in Premenopausal Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Treatment-Related Changes of Kupperman Index
研究概览
简要总结
The placental drug Melsmon® is effective for correction of insomnia and other climacteric symptoms in premenopausal women. Decrease of MMI is shown both in groups with Melsmon® and Placebo, but it was more significant in patients who used Melsmon®.
详细描述
There were 40 women under the observation, with mild and moderate symptoms of climacteric syndrome with sleep disorders (for that the investigators evaluated modified Kupperman Index).
All patients were randomized with the help of the envelope method with the allocation ratio of 1:1 (one-to-one). 20 women were prescribed placenta extract Melsmon and 20 received placebo during 4 months.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 52 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •More than 40 years of age
- •Irregular menstrual cycle
- •Climacteric symptoms, including sleep disorders
- •follicule-stimulating hormone >20 milli international units/ml -
排除标准
- •Non-controlled hypertension (more than 140 mm Hg)
- •Decompensated chronic diseases of the cardiovascular system, myocardial infarction, history of stroke
- •Diabetes mellitus
- •Kidney and hepatic dysfunction
- •Breast fibroadenomas, adenomas and cysts
- •Uterine fibroids with dominant nodule diameter ˃ 2 cm,
- •Endometrial hyperplasia
- •Individual drug idiosyncrasy
- •Intake of any drugs for correction of climacteric symptoms and sleep disorders
研究组 & 干预措施
Group 1 (Melsmon)
20 women used placental extract Melsmon® (Japan), 2 ml (100 mg), subcutaneously, every 2nd day for 2 weeks, then twice a week (30 injections for 4 months in total).
干预措施: Melsmon (Drug)
Group 2 (placebo)
20 patients used placebo (normal saline solution): 2 ml subcutaneously, every 2nd day for 2 weeks, then twice a week (30 injections for 4 months in total).
干预措施: Placebo (Other)
结局指标
主要结局
Treatment-Related Changes of Kupperman Index
时间窗: 4 months after the treatment
kupperman index scale (score)
次要结局
- Treatment-Related Changes of Menstrual Function(4 months after the treatment)
- Treatment-Related Changes of Depression Symptoms(4 months after the treatment)
- Treatment-Related Improvement in Skin Conditions(4 months after the treatment)
- Treatment-Related Changes of Sleep Quality(4 months after the treatment)
研究者
Inna I. Kovalenko
Gynecologist, PhD, Resercher at the Laboratory of Gynecological Endocrinology
Scientific Center for Family Health and Human Reproduction Problems, Russia