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

Phase 2

Completed

• Conditions: Climacteric Syndrome
• Interventions: Drug: Melsmon; Other: Placebo

• Registration Number: NCT02749695
• Lead Sponsor: Inna I. Kovalenko

Brief Summary

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

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 Timeline

• Study Start: 2013-10
• Primary Completion: 2014-08
• Study Completion: 2014-09
• Status Verified: 2016-04
• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-04-20
• Last Update Submitted: 2016-04-20
• Study First Posted: 2016-04-25
• Last Update Posted: 2016-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (Melsmon)	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).
Group 2 (placebo)	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).

Primary Outcome Measures

Name	Time	Method
Treatment-Related Changes of Kupperman Index	4 months after the treatment	kupperman index scale (score)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Scientific Center for Family Health and Human Reproduction Problems, Russia; 🇷🇺 Irkutsk, Russian Federation