NCT02749695

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Inna I. Kovalenko · Other Government
• Sex: Female
• Age: 40 Years – 52 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-08-01
• Completion: 2014-09-01
• First posted: 2016-04-25
• Last updated: 2016-04-25

Locations

1 site across 1 country: Russia