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

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02749695

Enrollment

Registered

2016-04-25

Start date

2013-10-31

Completion date

2014-09-30

Last updated

2016-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Climacteric Syndrome

Keywords

menopause, climacteric syndrome, insomnia, placental extract

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.

Interventions

DRUGMelsmon

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).

OTHERPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 52 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Treatment-Related Changes of Kupperman Index	4 months after the treatment	kupperman index scale (score)

Secondary

Measure	Time frame	Description
Treatment-Related Changes of Menstrual Function	4 months after the treatment	ultrasound assessment of endometrium growth (mm)
Treatment-Related Changes of Depression Symptoms	4 months after the treatment	kupperman index questionnaire (score)
Treatment-Related Improvement in Skin Conditions	4 months after the treatment	the questionnaire developed by the investigators (score)
Treatment-Related Changes of Sleep Quality	4 months after the treatment	Pittsburgh Sleep Quality Index (score)

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026