Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2026-02-20 @ 10:09 PM
Study NCT ID:
NCT01931657
Status:
COMPLETED
Last Update Posted:
2016-02-25
First Post:
2013-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pretreatment With Mifepristone Prior to Mirena Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015735', 'term': 'Mifepristone'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-24', 'studyFirstSubmitDate': '2013-08-25', 'studyFirstSubmitQcDate': '2013-08-25', 'lastUpdatePostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days with bleeding and spotting', 'timeFrame': 'During the first 3 months of Mirena use', 'description': 'To study the effect of pre-treatment with mifepristone on the initial bleeding pattern in women using LNG-IUS (Mirena)'}], 'secondaryOutcomes': [{'measure': 'Endometrial changes', 'timeFrame': '3 months post Mirena insertion', 'description': 'To study the effect of mifepristone pre treatment on the endometrium in women before and during treatment with Mirena with special regard to progesteron receptor modulator associated endometrial changes observed following continuos treatment with mifeprsitone (PAEC).'}, {'measure': 'Effects on breast tissue', 'timeFrame': 'Evaluated at end of mifeprsitone treatment', 'description': 'Breast biopsies are obtained at baseline and following 2 months treatment with mifepristone'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['LNG-IUS', 'Mirena', 'Contraception', 'Bleeding', 'Hormonal effects in the breast'], 'conditions': ['Women in Need of Long Acting Reversibel Cntraception With the Intrauterine Levonorgestrel Releasing System, Mirena']}, 'descriptionModule': {'briefSummary': 'Hypothesis: Pretreatment with mifeprsitone prior to Mirena placement will induce amenorrhea and reduce bleeding irrregularities during the initial months of Mirena use.', 'detailedDescription': 'The levonorgestrel releasing intrauterine system (IUS), Mirena, represents a highly effective contraceptive method that is cost-effective and requires limited patient effort. Furthermore Mirena offers numerous noncontraceptive benefits and addresses different medical needs for women in reproductive and non reproductive age. Side effects such as menstrual abnormalities are important reasons for early discontinuation of a contraceptive method. Irregular bleeding pattern and spotting represents a well known adverse effect during the first months of use with Mirena and corresponds to the most important factor that negatively influences the acceptability of the IUS. Up to today no standard treatment has been suggested to resolve this issue.\n\nBy inducing amenorrhea within a short period of treatment with an anti-progesterone, mifepristone, prior to insertion of Mirena, the bleeding irregularities during the first months of use might be reduced and could therefore represent an important strategy for increasing acceptability of this contraceptive system.\n\nThe purpose of the present study is to evaluate the bleeding pattern during the first months of use of Mirena in patients treated with mifepristone compared to placebo in women using Mirena for contraception. The study will also address the effect of mifepristone on endometrial morphology and breast tissue.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Pre-menopausal women, \\>/= 18 years of age.\n* Desire of Mirena for contraception\n* Good general health (as judged by; general physical examination\n* Willing and able to participate after giving informed consent\n\nExclusion criteria:\n\n* Any hormonal treatment or IUD use within 2 months prior to study start\n* History of malignant disorder of the breast\n* Any contraindication to mifepristone\n* Pregnancy or breast feeding within 2 months prior to study start'}, 'identificationModule': {'nctId': 'NCT01931657', 'acronym': 'MiMi', 'briefTitle': 'Pretreatment With Mifepristone Prior to Mirena Insertion', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Pre-treatment With Mifepristone in Patients With Mirena for Optimizing Bleeding Pattern in Pre-menopausal Women', 'orgStudyIdInfo': {'id': 'W2009M'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mifepristone prior to Mirena', 'description': 'Pretreatment with mifepristone prior to Mirena insertion', 'interventionNames': ['Drug: Mifepristone prior to Mirena']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo prior to Mirena', 'description': 'Pretreatment with placebo prior to Mirena insertion', 'interventionNames': ['Drug: Placebo prior to Mirena insertion']}], 'interventions': [{'name': 'Mifepristone prior to Mirena', 'type': 'DRUG', 'otherNames': ['Mifepristone'], 'armGroupLabels': ['Mifepristone prior to Mirena']}, {'name': 'Placebo prior to Mirena insertion', 'type': 'DRUG', 'armGroupLabels': ['Placebo prior to Mirena']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17176', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kristina Gemzell Danielsson', 'investigatorAffiliation': 'Karolinska Institutet'}}}}