Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 4:27 AM
Study NCT ID:
NCT06719934
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-06
First Post:
2024-11-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ttt of Adenomyosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D062788', 'term': 'Adenomyosis'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C023635', 'term': 'dienogest'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2024-11-27', 'studyFirstSubmitQcDate': '2024-12-02', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluation use of Dienogest versus uterine arteries embolization in treatment of Adenomyosis-associated symptoms as dysmenorrhea, heavy menstrual bleeding and bulk-related symptoms by questionnaire', 'timeFrame': 'through study completion ,an average of 1 year', 'description': 'evaluation use of Dienogest versus uterine arteries embolization in improvement of Adenomyosis-associated symptoms as dysmenorrhea, heavy menstrual bleeding and bulk-related symptoms by questionnaire'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adenomyosis']}, 'descriptionModule': {'briefSummary': 'to evaluate use of Dienogest versus uterine arteries embolization in treatment of Adenomyosis-associated symptoms as dysmenorrhea, heavy menstrual bleeding and bulk-related symptoms', 'detailedDescription': 'Type of the study: prospective cohort comparative study. Setting: It will be done at both Obstetrics \\& Gynecology department and Radiology department, Al-Azhar University Hospital Assiut branch.\n\nTime of the study: Starting from January 2025 till the end of the study Number of cases: 100 cases. According to sample size equation Where; in: n = number of patients, = 1.96 (standard normal deviate value that divides the central 95% of z distribution from 5% in the tails), P = the reported sensitivity (67%, i.e., 0.67), L= absolute precision desired on either side (half width of the confidence interval of the confidence interval) of sensitivity (10% i.e., 0.1).\n\nInclusion criteria:\n\n* Age Group: 30-50 years\n* Women with adenomyosis\n* With or without small fibroids\n* Suffering from heavy menstrual bleeding, dysmenorrhea, and/or cycle- independent pain and bulk-related symptoms.\n\nExclusion criteria:\n\n* Presence of a malignancy or pelvic infection.\n* An on-going pregnancy or a desire to conceive in the future.\n* Absolute contraindication for angiography (renal impairment).\n* Chronic debilitating diseases.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:- Age Group: 30-50 years\n\n* Women with adenomyosis\n* With or without small fibroids\n* Suffering from heavy menstrual bleeding, dysmenorrhea, and/or cycle- independent pain and bulk-related symptoms.\n\nExclusion Criteria:\n\n* \\- Presence of a malignancy or pelvic infection.\n* An on-going pregnancy or a desire to conceive in the future.\n* Absolute contraindication for angiography (renal impairment).\n* Chronic debilitating diseases.'}, 'identificationModule': {'nctId': 'NCT06719934', 'briefTitle': 'Ttt of Adenomyosis', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Dienogest Versus Uterine Artery Embolization in Ttt of Adenomyosis -cohort Comparetive Study', 'orgStudyIdInfo': {'id': '121212121212121212121212121212'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dienogest group', 'description': 'will take 2 mg oral Dienogest', 'interventionNames': ['Drug: Dienogest 2 mg orally']}, {'type': 'EXPERIMENTAL', 'label': 'Uterine artery embolization', 'description': 'will undergoes uterine artery embolization by local anasthesia', 'interventionNames': ['Procedure: UAE']}], 'interventions': [{'name': 'Dienogest 2 mg orally', 'type': 'DRUG', 'description': '2 mg Dienogest orally', 'armGroupLabels': ['Dienogest group']}, {'name': 'UAE', 'type': 'PROCEDURE', 'description': 'under local anasthesia uterine artery embolizationwill be done', 'armGroupLabels': ['Uterine artery embolization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71524', 'city': 'Asyut', 'state': 'Assuit', 'country': 'Egypt', 'contacts': [{'name': 'Gamal mohammed Abd El Moez', 'role': 'CONTACT', 'email': 'azhararabi46@yahoo.com', 'phone': '201006704553+'}], 'facility': 'Al Azhar university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'AL-Azhar university Assuit', 'role': 'CONTACT', 'email': 'Eshrq.arabi2020@gmail.com', 'phone': '0882148087'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assuit', 'investigatorFullName': 'Eshraq Arabi', 'investigatorAffiliation': 'Al-Azhar University'}}}}