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

NCT02749695 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-04-25

No results posted yet for this study

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

Interventions

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

Placebo

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

Sponsors & Collaborators

  • Inna I. Kovalenko

    lead OTHER_GOV

Principal Investigators

  • Larisa V. Suturina, M.D. · Scientific Center for Family Health and Human Reproduction Problems, Russia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
52 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-08-31
Completion
2014-09-30

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02749695 on ClinicalTrials.gov