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

NCT02749695 | Completed Phase 2

• 1 other identifier: Melsmon-913
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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®.

Conditions

Climacteric Syndrome

Keywords

menopause, climacteric syndrome, insomnia, placental extract

Outcome Measures

Primary Outcomes (1)

• Treatment-Related Changes of Kupperman Index

  kupperman index scale (score)

  4 months after the treatment

Secondary Outcomes (4)

• Treatment-Related Changes of Menstrual Function

  4 months after the treatment

• Treatment-Related Changes of Depression Symptoms

  4 months after the treatment

• Treatment-Related Improvement in Skin Conditions

  4 months after the treatment

• Treatment-Related Changes of Sleep Quality

  4 months after the treatment

Study Arms (2)

Group 1 (Melsmon)

EXPERIMENTAL

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

Group 2 (placebo)

PLACEBO COMPARATOR

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

Interventions

Melsmon DRUG

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).

Also known as: Melsmon Pharmaceutical Co., Ltd.

Group 1 (Melsmon)

Placebo OTHER

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

Also known as: Normal Saline Solution

Group 2 (placebo)

Eligibility Criteria

• Age: 40 Years - 52 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inna I. Kovalenko: lead

Study Sites (1)

Scientific Center for Family Health and Human Reproduction Problems, Russia

Irkutsk, 664003, Russia

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Long-Term Synaptic Depression; Saline Solution

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Larisa V. Suturina, M.D.

  Scientific Center for Family Health and Human Reproduction Problems, Russia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Gynecologist, PhD, Resercher at the Laboratory of Gynecological Endocrinology

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 25, 2016
• Study Start: October 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 25, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

RU (1)