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®.

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.

Inclusion Criteria:

• More than 40 years of age
• Irregular menstrual cycle
• Climacteric symptoms, including sleep disorders
• follicule-stimulating hormone >20 milli international units/ml -

Exclusion Criteria:

• 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
• Cancer
• 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

We plan to share all available IPD: age, body mass, character of menstrual disorder and climacteric syndromes, treatment regimen (for both experimental and placebo groups), Kupperman index, results of overall-health and sleep evaluation.

Until the publications are available, any concerned party can contact the researcher Inna I. Kovalenko (innakov2010@yandex.ru).