Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2026-01-03 @ 8:16 PM
Study NCT ID:
NCT03673995
Status:
COMPLETED
Last Update Posted:
2020-06-16
First Post:
2018-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D006628', 'term': 'Hirsutism'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014770', 'term': 'Virilism'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 186}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-13', 'studyFirstSubmitDate': '2018-08-22', 'studyFirstSubmitQcDate': '2018-09-13', 'lastUpdatePostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Restore of regular menstrual period', 'timeFrame': '6 months of treatment', 'description': 'Self report'}], 'secondaryOutcomes': [{'measure': 'Improving hirsutism', 'timeFrame': '6 months of treatment', 'description': 'Standardised visual scales are preferred when assessing hirsutism, such as the modified Ferriman Gallwey score (mFG) with a level ≥ 4 - 6 indicating hirsutism,'}, {'measure': 'Restore ovulation', 'timeFrame': '6 months of treatment', 'description': 'Progesterone value in luteal phase'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome', 'Menstrual Problem', 'Hirsutism']}, 'descriptionModule': {'briefSummary': 'PCOS patients were treated every day, with one sachet containing 2000 mg myo-inositol, 500 mg L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid. All patients underwent, before starting the therapy, after 3 months and 6 months, hormonal evaluation , hirsutism scoring and ovulation assesment. Most of them during the treatment improved their symptoms.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '38 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n° PCOS patients\n\nExclusion Criteria:\n\n* thyroid dysfunction\n* hyperprolactinemia\n* adrenal hyperplasia\n* patients taking oral contraceptive\n* any other endocrinological pathologies'}, 'identificationModule': {'nctId': 'NCT03673995', 'briefTitle': 'Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pharmarte srl'}, 'officialTitle': 'Use of Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS Women', 'orgStudyIdInfo': {'id': 'PharmarteLtyrosine1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Myo-inositol+L-tyrosine', 'description': 'One sachet per day containing 2000 mg myo-inositol, 500 mg L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid for improving PCOS symptoms.', 'interventionNames': ['Dietary Supplement: Myo-inositol+L-tyrosine']}], 'interventions': [{'name': 'Myo-inositol+L-tyrosine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'PCOS patients were treated every day, with one sachet containing 2000 mg myo-inositol, 500 mg L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid. All patients underwent, before starting the therapy, after 3 months and 6 months, hormonal, hirsutism and ovulation assesment.', 'armGroupLabels': ['Myo-inositol+L-tyrosine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00198', 'city': 'Roma', 'country': 'Italy', 'facility': 'Altamedica Reproductive Medicine', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'overallOfficials': [{'name': 'Mario Montanino Oliva, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Altamedica Reproductive Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pharmarte srl', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}