Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-02-09 @ 6:46 PM
Study NCT ID:
NCT02749695
Status:
COMPLETED
Last Update Posted:
2016-04-25
First Post:
2016-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficiency of Placental Drug Melsmon® in Correction of Climacteric Symptoms in Premenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D036881', 'term': 'Long-Term Synaptic Depression'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D009473', 'term': 'Neuronal Plasticity'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-20', 'studyFirstSubmitDate': '2016-04-12', 'studyFirstSubmitQcDate': '2016-04-20', 'lastUpdatePostDateStruct': {'date': '2016-04-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment-Related Changes of Kupperman Index', 'timeFrame': '4 months after the treatment', 'description': 'kupperman index scale (score)'}], 'secondaryOutcomes': [{'measure': 'Treatment-Related Changes of Menstrual Function', 'timeFrame': '4 months after the treatment', 'description': 'ultrasound assessment of endometrium growth (mm)'}, {'measure': 'Treatment-Related Changes of Depression Symptoms', 'timeFrame': '4 months after the treatment', 'description': 'kupperman index questionnaire (score)'}, {'measure': 'Treatment-Related Improvement in Skin Conditions', 'timeFrame': '4 months after the treatment', 'description': 'the questionnaire developed by the investigators (score)'}, {'measure': 'Treatment-Related Changes of Sleep Quality', 'timeFrame': '4 months after the treatment', 'description': 'Pittsburgh Sleep Quality Index (score)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['menopause, climacteric syndrome, insomnia, placental extract'], 'conditions': ['Climacteric Syndrome']}, 'descriptionModule': {'briefSummary': '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®.', 'detailedDescription': '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).\n\nAll 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '52 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* More than 40 years of age\n* Irregular menstrual cycle\n* Climacteric symptoms, including sleep disorders\n* follicule-stimulating hormone \\>20 milli international units/ml -\n\nExclusion Criteria:\n\n* Non-controlled hypertension (more than 140 mm Hg)\n* Decompensated chronic diseases of the cardiovascular system, myocardial infarction, history of stroke\n* Diabetes mellitus\n* Kidney and hepatic dysfunction\n* Cancer\n* Breast fibroadenomas, adenomas and cysts\n* Uterine fibroids with dominant nodule diameter ˃ 2 cm,\n* Endometrial hyperplasia\n* Individual drug idiosyncrasy\n* Intake of any drugs for correction of climacteric symptoms and sleep disorders'}, 'identificationModule': {'nctId': 'NCT02749695', 'briefTitle': 'Efficiency of Placental Drug Melsmon® in Correction of Climacteric Symptoms in Premenopausal Women', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Scientific Center for Family Health and Human Reproduction Problems, Russia'}, 'officialTitle': 'The Prospective, Blind, Randomized, Placebo-controlled, 4 Months Study of Efficacy of Melsmon® for Correction of Insomnia and Other Climacteric Symptoms in Premenopausal Women', 'orgStudyIdInfo': {'id': 'Melsmon-913'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 (Melsmon)', '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).', 'interventionNames': ['Drug: Melsmon']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 2 (placebo)', '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).', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Melsmon', 'type': 'DRUG', 'otherNames': ['Melsmon Pharmaceutical Co., Ltd.'], 'description': '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).', 'armGroupLabels': ['Group 1 (Melsmon)']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Normal Saline Solution'], 'description': '2 ml subcutaneously, every 2nd day for 2 weeks, then twice a week (30 injections for 4 months in total).', 'armGroupLabels': ['Group 2 (placebo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '664003', 'city': 'Irkutsk', 'country': 'Russia', 'facility': 'Scientific Center for Family Health and Human Reproduction Problems, Russia', 'geoPoint': {'lat': 52.29566, 'lon': 104.29076}}], 'overallOfficials': [{'name': 'Larisa V. Suturina, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Scientific Center for Family Health and Human Reproduction Problems, Russia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'We plan to share all available IPD: age, body mass, character of menstrual disorder and climacteric syndromes, treatment regimen (for both experimental and placebo groups), Kupperman index, results of overall-health and sleep evaluation.\n\nUntil the publications are available, any concerned party can contact the researcher Inna I. Kovalenko (innakov2010@yandex.ru).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inna I. Kovalenko', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Gynecologist, PhD, Resercher at the Laboratory of Gynecological Endocrinology', 'investigatorFullName': 'Inna I. Kovalenko', 'investigatorAffiliation': 'Scientific Center for Family Health and Human Reproduction Problems, Russia'}}}}