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

NCT ID: NCT02749695

Last Updated: 2016-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-09-30

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.

Conditions

Climacteric Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Melsmon

Intervention Type: 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).

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).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

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).

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Other Intervention Names

Melsmon Pharmaceutical Co., Ltd.; Normal Saline Solution

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 52 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Inna I. Kovalenko

OTHER_GOV

Sponsor Role: lead

Responsible Party

Inna I. Kovalenko

Gynecologist, PhD, Resercher at the Laboratory of Gynecological Endocrinology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Larisa V. Suturina, M.D.

Role: STUDY_DIRECTOR

Scientific Center for Family Health and Human Reproduction Problems, Russia

Locations

Scientific Center for Family Health and Human Reproduction Problems, Russia

Irkutsk, , Russia

Countries

Russia

Other Identifiers

Melsmon-913

Identifier Type: -

Identifier Source: org_study_id