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Completed

NCT Number: NCT02749695

Efficiency of Placental Drug Melsmon® in Correction of 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®.

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Key information

Conditions

Climacteric Syndrome Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

40 year–52 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Scientific Center for Family Health and Human Reproduction Problems, Russia

Irkutsk, 664003, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: Melsmon Pharmaceutical Co., Ltd.

Placebo

Other

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

Primary outcomes

  1. Treatment-Related Changes of Kupperman Index

    Time frame: 4 months after the treatment

    kupperman index scale (score)

Secondary outcomes

  1. Treatment-Related Changes of Menstrual Function

    Time frame: 4 months after the treatment

    ultrasound assessment of endometrium growth (mm)

  2. Treatment-Related Changes of Depression Symptoms

    Time frame: 4 months after the treatment

    kupperman index questionnaire (score)

  3. Treatment-Related Improvement in Skin Conditions

    Time frame: 4 months after the treatment

    the questionnaire developed by the investigators (score)

  4. Treatment-Related Changes of Sleep Quality

    Time frame: 4 months after the treatment

    Pittsburgh Sleep Quality Index (score)

Sponsors and collaborators

Lead sponsor

Inna I. Kovalenko

Other Gov

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 25, 2016
Registry last updated
Apr 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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