Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-30 @ 9:11 AM
Study NCT ID:
NCT00884260
Status:
COMPLETED
Last Update Posted:
2014-08-21
First Post:
2009-04-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GA Levonorgestrel Intrauterine Contraceptive System (LCS) Phase III Study China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 918}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-20', 'studyFirstSubmitDate': '2009-04-16', 'studyFirstSubmitQcDate': '2009-04-17', 'lastUpdatePostDateStruct': {'date': '2014-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary efficacy variable is the occurrence of pregnancy, the Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'LCS expulsion rate', 'timeFrame': '3 years'}, {'measure': 'Discontinuation rates', 'timeFrame': '3 years'}, {'measure': 'Adverse events', 'timeFrame': '3 years'}, {'measure': 'Laboratory tests', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contraception', 'Intrauterine contraception system'], 'conditions': ['Contraception']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy, safety, bleeding pattern of low dose LNG (12 mg/ 24 hrs), delivered locally by a new intrauterine contraceptive system suitable for use by women 18 to 40 years of age. In addition, pharmacokinetic assessments will be performed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has, in the opinion of the investigator, suitable general and uterine conditions for inserting the LCS.\n* Normal cervical smear (normal cervical smear within the last six months prior to visit 1 presented in writing can be accepted. The cervical smear should be analyzed and reported according to the Bethesda System.)\n* Has clinically normal safety laboratory results (i.e., inside the specified range for inclusion).\n* Has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity without hormonal contraceptive use).\n\nExclusion Criteria:\n\n* Known or suspected pregnancy or is lactating.\n* Vaginal delivery, cesarean delivery, or abortion within 6 weeks prior to visit 2.\n\nNote: Postpartum insertions should be postponed until uterus is fully involuted, however not earlier than 6 weeks after delivery. If involution is substantially delayed, consider waiting until 12 weeks postpartum. In case of a difficult insertion and/or exceptional pain or bleeding during or after insertion, physical examination and ultrasound should be performed immediately to exclude perforation.\n\n* History of ectopic pregnancies. Note: For Korea only: History of ectopic pregnancies or high probability of ectopic gestation.\n* Infected abortion within 3 months prior to visit 1. Note: For Korea only: Endometritis after delivery or infected abortion within 3 months prior to visit 1.\n* Abnormal uterine bleeding of unknown origin.\n* Any genital infection (until successfully treated).\n* History of, or current, pelvic inflammatory disease\n* Congenital or acquired uterine anomaly.\n* Any distortion of the uterine cavity (by e.g., fibroids) likely to cause problems (in the opinion of the investigator) during insertion, retention or removal of the LCS.\n* History of, diagnosed or suspected genital malignancy, and untreated cervical dysplasia.\n* Current deep venous thrombosis or thrombophlebitis; history of deep venous thrombosis.\n* Clinically significant endometrial polyp(s), which, in the opinion of the investigator, will interfere with the assessment of the bleeding profile during the study\n* Clinically significant ovarian cyst(s)\n* Use of any long-acting injectable sex-hormone preparations within 12 months prior to start of study medication, and if entering subset: any sex-hormone administration within one month prior to start of the study medication.'}, 'identificationModule': {'nctId': 'NCT00884260', 'briefTitle': 'GA Levonorgestrel Intrauterine Contraceptive System (LCS) Phase III Study China', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Multi-center, Open Label, Single Arm Study to Assess Efficacy, Safety, Bleeding Pattern and Pharmacokinetics of the Ultra Low Dose Levonorgestrel Intrauterine Contraceptive System (LCS) for a Maximum of 3 Years in Women 18 to 40 Years of Age', 'orgStudyIdInfo': {'id': '91775'}, 'secondaryIdInfos': [{'id': 'MAGIC', 'type': 'OTHER', 'domain': 'company internal'}, {'id': '311966', 'type': 'OTHER', 'domain': 'company internal'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Levonorgestrel IUS (LCS, BAY86-5028)']}], 'interventions': [{'name': 'Levonorgestrel IUS (LCS, BAY86-5028)', 'type': 'DRUG', 'description': 'In Vitro release rate: 12µg LNG/24h', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2031', 'city': 'Ashfield', 'state': 'New South Wales', 'country': 'Australia', 'geoPoint': {'lat': -33.88834, 'lon': 151.12274}}, {'zip': '4029', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '3052', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '6008', 'city': 'Subiaco', 'state': 'Western Australia', 'country': 'Australia', 'geoPoint': {'lat': -31.9485, 'lon': 115.8268}}, {'zip': '510405', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '116011', 'city': 'Dalian', 'state': 'Liaoning', 'country': 'China', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '100034', 'city': 'Beijing', 'country': 'China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100191', 'city': 'Beijing', 'country': 'China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'country': 'China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '400010', 'city': 'Chongqing', 'country': 'China', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '400042', 'city': 'Chongqing', 'country': 'China', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '200011', 'city': 'Shanghai', 'country': 'China', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200025', 'city': 'Shanghai', 'country': 'China', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200127', 'city': 'Shanghai', 'country': 'China', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '463-712', 'city': 'Sungnam-si', 'state': 'Gyeonggido', 'country': 'South Korea'}, {'zip': '100-380', 'city': 'Seoul', 'state': 'Korea', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}