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

Study Overview
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Brief Summary
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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®.

Detailed Description
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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.

Official Title
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The Prospective, Blind, Randomized, Placebo-controlled, 4 Months Study of Efficacy of Melsmon® for Correction of Insomnia and Other Climacteric Symptoms in Premenopausal Women

Conditions
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Climacteric Syndrome

Intervention / Treatment
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* Drug: Melsmon
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 52 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 (Melsmon)<br>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). | Drug: Melsmon<br>* 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).<br>* Other names: Melsmon Pharmaceutical Co., Ltd.;|
| Placebo Comparator: Group 2 (placebo)<br>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). | Other: Placebo<br>* 2 ml subcutaneously, every 2nd day for 2 weeks, then twice a week (30 injections for 4 months in total).<br>* Other names: Normal Saline Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-Related Changes of Kupperman Index | kupperman index scale (score) | 4 months after the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-Related Changes of Menstrual Function | ultrasound assessment of endometrium growth (mm) | 4 months after the treatment | 
| Treatment-Related Changes of Depression Symptoms | kupperman index questionnaire (score) | 4 months after the treatment | 
| Treatment-Related Improvement in Skin Conditions | the questionnaire developed by the investigators (score) | 4 months after the treatment | 
| Treatment-Related Changes of Sleep Quality | Pittsburgh Sleep Quality Index (score) | 4 months after the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menopause, climacteric syndrome, insomnia, placental extract