Status:
COMPLETED
Efficiency of Placental Drug Melsmon® in Correction of Climacteric Symptoms in Premenopausal Women
Lead Sponsor:
Inna I. Kovalenko
Conditions:
Climacteric Syndrome
Eligibility:
FEMALE
40-52 years
Phase:
PHASE2
PHASE3
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...
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 w...
Eligibility Criteria
Inclusion
- More than 40 years of age
- Irregular menstrual cycle
- Climacteric symptoms, including sleep disorders
- follicule-stimulating hormone \>20 milli international units/ml -
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02749695
Start Date
October 1 2013
End Date
September 1 2014
Last Update
April 25 2016
Active Locations (1)
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1
Scientific Center for Family Health and Human Reproduction Problems, Russia
Irkutsk, Russia, 664003