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

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

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®.

Study Overview

• Status: Completed
• Conditions: Climacteric Syndrome
• Intervention / Treatment: Drug: Melsmon; Other: Placebo

Detailed Description

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
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Irkutsk, Russian Federation, 664003
    • Scientific Center for Family Health and Human Reproduction Problems, Russia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 52 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Inna I. Kovalenko
• Investigators: Study Director: Larisa V. Suturina, M.D., Scientific Center for Family Health and Human Reproduction Problems, Russia

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: April 12, 2016
• First Submitted That Met QC Criteria: April 20, 2016
• First Posted (Estimate): April 25, 2016

Study Record Updates

• Last Update Posted (Estimate): April 25, 2016
• Last Update Submitted That Met QC Criteria: April 20, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: menopause, climacteric syndrome, insomnia, placental extract
• Other Study ID Numbers: Melsmon-913

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

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).