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

Inna I. Kovalenko

Status and phase: Completed; Phase 3; Phase 2

Conditions: Climacteric Syndrome

Treatments: Other: Placebo; Drug: Melsmon

Study type: Interventional

Funder types: Other

Identifiers

NCT02749695

Melsmon-913

Details and patient eligibility

About

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®.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 40 to 52 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Group 1 (Melsmon)

Experimental group

Description:

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).

Treatment:

Drug: Melsmon

Group 2 (placebo)

Placebo Comparator group

Description:

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).

Treatment:

Other: Placebo