Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-26 @ 12:30 AM
Study NCT ID:
NCT01266759
Status:
COMPLETED
Last Update Posted:
2010-12-24
First Post:
2010-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Combined Contraceptive Vaginal Ring(NuvaRing)in Women With Idiopathic Menorrhagia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008595', 'term': 'Menorrhagia'}], 'ancestors': [{'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'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': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C516519', 'term': 'NuvaRing'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-23', 'studyFirstSubmitDate': '2010-12-22', 'studyFirstSubmitQcDate': '2010-12-23', 'lastUpdatePostDateStruct': {'date': '2010-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in menstrual blood loss at the end of study (cycle 3) measured by pictorial blood loss assessment chart.'}], 'secondaryOutcomes': [{'measure': 'Haemoglobin and serum ferritin at the end of study (cycle 3)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Menorrhagia', 'Vaginal ring', 'Norethisterone Acetate'], 'conditions': ['Menorrhagia']}, 'referencesModule': {'references': [{'pmid': '18635169', 'type': 'BACKGROUND', 'citation': 'Matteson KA, Boardman LA, Munro MG, Clark MA. Abnormal uterine bleeding: a review of patient-based outcome measures. Fertil Steril. 2009 Jul;92(1):205-16. doi: 10.1016/j.fertnstert.2008.04.023. Epub 2008 Jul 16.'}, {'pmid': '15539438', 'type': 'BACKGROUND', 'citation': 'Oddsson K, Leifels-Fischer B, Wiel-Masson D, de Melo NR, Benedetto C, Verhoeven CH, Dieben TO. Superior cycle control with a contraceptive vaginal ring compared with an oral contraceptive containing 30 microg ethinylestradiol and 150 microg levonorgestrel: a randomized trial. Hum Reprod. 2005 Feb;20(2):557-62. doi: 10.1093/humrep/deh604. Epub 2004 Nov 11.'}]}, 'descriptionModule': {'briefSummary': 'To compare the efficacy of a combined contraceptive vaginal ring (NuvaRing) and oral Norethisterone Acetate in treatment of Idiopathic heavy menstrual bleeding during fertile age'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with heavy menstrual bleeding based on PBAC score over 185 (mean of two control cycles)and desire contraception\n\nExclusion Criteria:\n\n* Menorrhagia of endocrine or systemic origin\n* other pathology e.g. patients with fibroids of any size, adenomyosis, endometriosis, pelvic inflammatory disease.'}, 'identificationModule': {'nctId': 'NCT01266759', 'briefTitle': 'Efficacy of Combined Contraceptive Vaginal Ring(NuvaRing)in Women With Idiopathic Menorrhagia', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Combined Contraceptive Vaginal Ring or Norethisterone for Treatment of Idiopathic Menorrhagia', 'orgStudyIdInfo': {'id': 'MU-261z'}, 'secondaryIdInfos': [{'id': 'FMH-245-C'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NuvaRing', 'description': 'For the first cycle, women inserted the ring between days 1 and 5 of the menstrual cycle. Treatment continued for three cycles. Each cycle consisted of 3 weeks of ring use followed by a 1 week ring-free period.', 'interventionNames': ['Drug: NuvaRing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Norethisterone Acetate', 'description': 'Norethisterone Acetate tablets at a dose of 5 mg three times daily from day 5 to 26 of the cycle over three cycles. Male condom used for contraception during treatment', 'interventionNames': ['Drug: Norethisterone Acetate tablets - 5mg']}], 'interventions': [{'name': 'NuvaRing', 'type': 'DRUG', 'description': 'For the first cycle, women inserted the ring between days 1 and 5 of the menstrual cycle. Treatment continued for three cycles. Each cycle consisted of 3 weeks of ring use followed by a 1 week ring-free period.', 'armGroupLabels': ['NuvaRing']}, {'name': 'Norethisterone Acetate tablets - 5mg', 'type': 'DRUG', 'description': 'Norethisterone Acetate tablets 5 mg three times daily from day 5 to 26 of the cycle over three cycles. Male condom used for contraception during treatment', 'armGroupLabels': ['Norethisterone Acetate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Mansoura University Hospitals,OB/GYN department', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Hatem Abu Hashim, MD MRCOG', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University Hospital'}, {'name': 'Waleed El-Sherbini, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mansoura University Hospital'}, {'name': 'Mohamed Bazeed, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mansoura University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Hatem Abu Hashim, Associate Prof. of OB/GYN', 'oldOrganization': 'Mansoura Faculty of Medicine, Mansoura University.'}}}}