Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-31 @ 5:45 PM
Study NCT ID:
NCT00453960
Status:
COMPLETED
Last Update Posted:
2008-12-19
First Post:
2007-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genistein and Endometrial Hyperplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004714', 'term': 'Endometrial Hyperplasia'}, {'id': 'D008796', 'term': 'Metrorrhagia'}], 'ancestors': [{'id': 'D014591', 'term': 'Uterine 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': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077563', 'term': 'Norethindrone Acetate'}], 'ancestors': [{'id': 'D009640', 'term': 'Norethindrone'}, {'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-18', 'studyFirstSubmitDate': '2007-03-28', 'studyFirstSubmitQcDate': '2007-03-28', 'lastUpdatePostDateStruct': {'date': '2008-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recovery from endometrial hyperplasia', 'timeFrame': '3-6 months'}], 'secondaryOutcomes': [{'measure': 'Differential expression of ER-a and ER-b in endometrial specimens', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Endometrial hyperplasia', 'Genistein', 'Isoflavones', 'dysfunctional uterine bleeding'], 'conditions': ['Endometrial Hyperplasia']}, 'referencesModule': {'references': [{'pmid': '12466350', 'type': 'RESULT', 'citation': 'Kayisli UA, Aksu CA, Berkkanoglu M, Arici A. Estrogenicity of isoflavones on human endometrial stromal and glandular cells. J Clin Endocrinol Metab. 2002 Dec;87(12):5539-44. doi: 10.1210/jc.2002-020716.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to verify the anti-estrogenic activity of Genistein, on the "non atypical endometrial hyperplasia", in premenopausal women.', 'detailedDescription': 'Although isoflavones alone (example: Genistein) have weak estrogenic effects on endometrial stromal and glandular cells, it was demonstrated, in several research efforts, that in the presence of E2 they act as antiestrogens.\n\nConsidered that endometrial hyperplasia is due to strong and extended estrogenic stimulation, not offset by a proportionate amount of progesterone, we suppose that genistein could be therapeutic in these cases inducing a decrease of the hyperplasia and a change from the proliferative to a secretory phase of the endometrium.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '44 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premenopausal women\n* Age \\> = 44 years\n* Dysfunctional uterine bleeding\n* No treatment with other hormonal drugs (estrogen, progesterone)\n* No local or general pathology negatively influenced by administration of genistein or progesterone\n* No intrauterine pathologies (polyps, myomas)\n* A "non atypical endometrial hyperplasia", confirmed by hysteroscopy with biopsy and histological examination\n\nExclusion Criteria:\n\n* All the other conditions'}, 'identificationModule': {'nctId': 'NCT00453960', 'briefTitle': 'Genistein and Endometrial Hyperplasia', 'organization': {'class': 'OTHER', 'fullName': 'University of Messina'}, 'officialTitle': 'Effect of Genistein on Endometrial Hyperplasia', 'orgStudyIdInfo': {'id': 'Roberta Granese, MD, PhD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Genistein', 'description': 'Genistein 54 mg/day', 'interventionNames': ['Dietary Supplement: Genivis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Norethisterone Acetate', 'description': 'Norethisterone Acetate 10mg/day', 'interventionNames': ['Drug: Norethisterone Acetate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablets, daily', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'Genivis', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Fosteum'], 'description': '54 mg/day daily for 6 months', 'armGroupLabels': ['Genistein']}, {'name': 'Norethisterone Acetate', 'type': 'DRUG', 'description': 'tablets 10mg/day from day 16 to 25 of menstruation', 'armGroupLabels': ['Norethisterone Acetate']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'tablets daily for 6 months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98100', 'city': 'Messina', 'country': 'Italy', 'facility': 'Menopause Centre, Department of Gynecology and Obstetrics, Policlinico Universitario "G.Martino"', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}], 'overallOfficials': [{'name': "Rosario D'Anna, prof.", 'role': 'STUDY_DIRECTOR', 'affiliation': 'menopause centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Messina', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'University of Messina', 'oldOrganization': 'University of Messina'}}}}