Efficiency of Placental Drug Melsmon® in Correction of Climacteric Symptoms in Premenopausal Women

Inna I. Kovalenko40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Climacteric Syndrome

Interventions

MelsmonDRUG

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).

PlaceboOTHER

2 ml subcutaneously, every 2nd day for 2 weeks, then twice a week (30 injections for 4 months in total).

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 52 Years

Medical Language ↔ Plain English

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

Locations (1)

Scientific Center for Family Health and Human Reproduction Problems, Russia

Irkutsk, Russia