Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 4:29 AM
Study NCT ID:
NCT01295294
Status:
COMPLETED
Last Update Posted:
2014-11-04
First Post:
2011-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Initial Bleeding/Spotting Associated With the Levonorgestrel-releasing Intrauterine System (MIRENA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014592', 'term': 'Uterine Hemorrhage'}], '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': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D008528', 'term': 'Mefenamic Acid'}, {'id': 'D016912', 'term': 'Levonorgestrel'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D054361', 'term': 'Fenamates'}, {'id': 'D062367', 'term': 'ortho-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009644', 'term': 'Norgestrel'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-02', 'studyFirstSubmitDate': '2011-02-11', 'studyFirstSubmitQcDate': '2011-02-11', 'lastUpdatePostDateStruct': {'date': '2014-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary efficacy variable will be the cumulative number of bleeding / spotting days', 'timeFrame': 'During 90 day double-blind treatment period'}], 'secondaryOutcomes': [{'measure': 'To describe and compare the bleeding patterns observed in women during treatment period', 'timeFrame': '90 day treatment period'}, {'measure': 'To describe and compare the bleeding patterns observed in women during follow-up period', 'timeFrame': 'During the 30 day follow-up period'}, {'measure': 'Satisfaction with oral blinded study drug treatment for bleeding / spotting', 'timeFrame': '90 day treatment period'}, {'measure': 'Occurrence of dysmenorrhea', 'timeFrame': 'During 120 day study period'}, {'measure': 'Continuation rate with study drug', 'timeFrame': 'During the 90 day treatment period'}, {'measure': 'Continuation rate with Mirena', 'timeFrame': 'During 120 day study period'}, {'measure': 'Adverse Events Collection', 'timeFrame': 'Until day 120'}, {'measure': 'Number of spotting-only days', 'timeFrame': 'During the 90-day treatment period'}, {'measure': 'Number of bleeding / spotting episodes', 'timeFrame': 'During the 90-day treatment period'}, {'measure': 'Length of bleeding / spotting episodes', 'timeFrame': 'During the 90-day treatment period'}, {'measure': 'Number of bleeding days with heavy intensity', 'timeFrame': 'During the 90-day treatment period'}, {'measure': 'Change in the number of B/S days between Day 60 and Day 90 of MIRENA use and the 30-day follow-up period', 'timeFrame': 'Up to day 120'}, {'measure': 'Satisfaction with levonorgestrel-releasing intrauterine system', 'timeFrame': 'Up to day 120'}, {'measure': 'Number of days of pain medication for dysmenorrhea during the 90 day treatment period', 'timeFrame': 'During the 90-day treatment period'}, {'measure': 'Number of bleeding-only days', 'timeFrame': 'During the 90-day treatment period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Uterine Hemorrhage', 'Contraception', 'Contraceptive Methods', 'Intrauterine devices', 'Mirena'], 'conditions': ['Uterine Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '23635728', 'type': 'DERIVED', 'citation': "Sordal T, Inki P, Draeby J, O'Flynn M, Schmelter T. Management of initial bleeding or spotting after levonorgestrel-releasing intrauterine system placement: a randomized controlled trial. Obstet Gynecol. 2013 May;121(5):934-941. doi: 10.1097/AOG.0b013e31828c65d8."}], 'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu', 'label': 'Click here and search for information of Bayer products for Europe'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate if the study drugs (tranexamic acid or mefenamic acid) can control irregular bleeding during the first 3 months of using Mirena. The study drugs tested are tested against placebo ("dummy medication not containing any active drug"). Treatment period is followed by a one-month period when study drugs are not taken but Mirena use is continued.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed and dated informed consent\n* Healthy female subjects requesting contraception\n* Age: 18 - 45 years inclusive\n* Successful interval insertion of MIRENA\n* History of regular cyclic menstrual periods\n* Normal or clinically insignificant cervical smear not requiring further follow up\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Climacteric symptoms prior to the screening visit\n* Known or suspected clinically significant ovarian cysts, endometrial polyps, fibroids, or other genital organ pathology, that, in the opinion of the investigator, may interfere with the assessment of the bleeding profile during the study\n* Undiagnosed abnormal genital bleeding\n* Current or history of thrombembolic disease, or established risk factors for venous thromboembolism\n* Current migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia, or exceptionally severe headaches\n* Hypersensitivity to any ingredient of the investigational medicinal products or the non-investigational medicinal product\n* Daily or frequent use of a nonsteroidal anti-inflammatory drug (NSAIDs) for any condition\n* Not willing to use nonsteroidal anti-inflammatory drug (NSAIDs) medication as pain medication during the double blind treatment period'}, 'identificationModule': {'nctId': 'NCT01295294', 'briefTitle': 'Management of Initial Bleeding/Spotting Associated With the Levonorgestrel-releasing Intrauterine System (MIRENA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'International, Prospective, Double-blind, 3-arm Comparative, Randomized, Placebo-controlled Phase IV Study on the Effect of Counseling and Either Tranexamic Acid or Mefenamic Acid or Placebo, on the Management of Bleeding/Spotting in Women Using the Levonorgestrel-releasing Intrauterine System (MIRENA) for Contraception.', 'orgStudyIdInfo': {'id': '15105'}, 'secondaryIdInfos': [{'id': '2010-020922-16', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tranexamic acid + Mirena (Levonorgestrel IUS, BAY86-5028)', 'description': 'Subjects with successful MIRENA insertion will receive treatments with tranexamic acid', 'interventionNames': ['Drug: Tranexamic acid', 'Drug: Mirena (Levonorgestrel IUS, BAY86-5028)']}, {'type': 'EXPERIMENTAL', 'label': 'mefenamic acid + Mirena (Levonorgestrel IUS, BAY86-5028)', 'description': 'Subjects with successful MIRENA insertion will receive treatments with mefenamic acid', 'interventionNames': ['Drug: Mefenamic acid', 'Drug: Mirena (Levonorgestrel IUS, BAY86-5028)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo + Mirena (Levonorgestrel IUS, BAY86-5028)', 'description': 'Subjects with successful MIRENA insertion will receive placebo', 'interventionNames': ['Drug: Placebo', 'Drug: Mirena (Levonorgestrel IUS, BAY86-5028)']}], 'interventions': [{'name': 'Tranexamic acid', 'type': 'DRUG', 'description': '500 mg 3 times daily per oral during bleeding/spotting episodes', 'armGroupLabels': ['tranexamic acid + Mirena (Levonorgestrel IUS, BAY86-5028)']}, {'name': 'Mefenamic acid', 'type': 'DRUG', 'description': '500 mg 3 times daily per oral during bleeding/spotting episodes', 'armGroupLabels': ['mefenamic acid + Mirena (Levonorgestrel IUS, BAY86-5028)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '3 times daily per oral during bleeding/spotting episodes', 'armGroupLabels': ['placebo + Mirena (Levonorgestrel IUS, BAY86-5028)']}, {'name': 'Mirena (Levonorgestrel IUS, BAY86-5028)', 'type': 'DRUG', 'description': 'In vitro release rate 20 microgram/24 hours. Intrauterine system', 'armGroupLabels': ['mefenamic acid + Mirena (Levonorgestrel IUS, BAY86-5028)', 'placebo + Mirena (Levonorgestrel IUS, BAY86-5028)', 'tranexamic acid + Mirena (Levonorgestrel IUS, BAY86-5028)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-9000', 'city': 'Aalborg', 'country': 'Denmark', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': 'DK-8000', 'city': 'Århus C', 'country': 'Denmark'}, {'zip': 'DK-2400', 'city': 'København NV', 'country': 'Denmark', 'geoPoint': {'lat': 55.71258, 'lon': 12.52343}}, {'zip': 'DK-5000', 'city': 'Odense C', 'country': 'Denmark', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}, {'zip': 'DK-7800', 'city': 'Skive', 'country': 'Denmark', 'geoPoint': {'lat': 56.56699, 'lon': 9.02707}}, {'zip': 'DK-2860', 'city': 'Søborg', 'country': 'Denmark', 'geoPoint': {'lat': 56.08481, 'lon': 12.31803}}, {'city': 'Mallow', 'state': 'Cork', 'country': 'Ireland', 'geoPoint': {'lat': 52.13333, 'lon': -8.63333}}, {'city': 'Blackrock', 'state': 'Dublin', 'country': 'Ireland', 'geoPoint': {'lat': 53.3015, 'lon': -6.1778}}, {'city': 'Cork', 'country': 'Ireland', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}, {'zip': '2403', 'city': 'Elverum', 'country': 'Norway', 'geoPoint': {'lat': 60.88191, 'lon': 11.56231}}, {'zip': '5507', 'city': 'Haugesund', 'country': 'Norway', 'geoPoint': {'lat': 59.41378, 'lon': 5.268}}, {'zip': '7012', 'city': 'Trondheim', 'country': 'Norway', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}