Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT00528112
Status:
COMPLETED
Last Update Posted:
2017-01-25
First Post:
2007-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Russia']}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayer.com', 'title': 'Therapeutic Area Head', 'organization': 'BAYER'}, 'certainAgreement': {'otherDetails': "Principal investigators (PIs) have to send the publication to sponsor 90 days prior to planned publishing. The sponsor has maximum 60 days for review and for recommending changes or mark parts that have to be deleted from the publication due to harming sponsor's confidentiality rights. Sponsor can request a delay in publication release up to 6 months.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of treatment until end of study, up to 5 years.', 'eventGroups': [{'id': 'EG000', 'title': 'LCS12, up to 3 Years', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro. Treatment up to 3 years.', 'otherNumAtRisk': 1432, 'otherNumAffected': 952, 'seriousNumAtRisk': 1432, 'seriousNumAffected': 66}, {'id': 'EG001', 'title': 'LCS16, up to 3 Years', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro. Treatment up to 3 years.', 'otherNumAtRisk': 1452, 'otherNumAffected': 1014, 'seriousNumAtRisk': 1452, 'seriousNumAffected': 72}, {'id': 'EG002', 'title': 'LCS16, up to 5 Years', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro. Treatment up to 5 years.', 'otherNumAtRisk': 1452, 'otherNumAffected': 1054, 'seriousNumAtRisk': 1452, 'seriousNumAffected': 86}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 98}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 102}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 74}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 58}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 59}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 92}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 100}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 103}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 109}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 122}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 96}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 107}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 156}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 148}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 167}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 73}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 74}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 86}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Vaginitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 105}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 128}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 150}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 108}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 126}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 71}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 76}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 65}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 80}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 132}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 137}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 146}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 107}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 116}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 147}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 130}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 109}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 116}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 186}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 303}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 337}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 122}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 132}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 73}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 80}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 163}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 170}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 179}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'seriousEvents': [{'term': 'Spherocytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Mitral valve prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Iridocyclitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Abdominal adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Impaired gastric emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Salivary gland calculus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Gallbladder polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Campylobacter gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 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'numAtRisk': 1452, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Strangury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Stress urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Ovarian cyst ruptured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Ovarian cyst torsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Haemorrhagic ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Vaginal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Detoxification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1432, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1452, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1452, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pearl Index up to 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1432', 'groupId': 'OG000'}, {'value': '1452', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro'}, {'id': 'OG001', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro'}], 'classes': [{'categories': [{'measurements': [{'value': '0.33', 'groupId': 'OG000', 'lowerLimit': '0.16', 'upperLimit': '0.60'}, {'value': '0.31', 'groupId': 'OG001', 'lowerLimit': '0.15', 'upperLimit': '0.57'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'failure rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.009', 'ciLowerLimit': '0.005', 'ciUpperLimit': '0.017', 'groupDescription': 'Cumulative failure rate (Kaplan-Meier) at 3 years', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'failure rate', 'ciPctValue': '95', 'paramValue': 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Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.", 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the full analysis set who had an assessment for this evaluation'}, {'type': 'SECONDARY', 'title': 'Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1262', 'groupId': 'OG000'}, {'value': '1300', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro'}, {'id': 'OG001', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro'}], 'classes': [{'title': 'Number of bleeding/spotting days', 'categories': [{'measurements': [{'value': '23.3', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '21.1', 'spread': '15.1', 'groupId': 'OG001'}]}]}, {'title': 'Number of bleeding days', 'categories': [{'measurements': [{'value': '10.2', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '9.1', 'groupId': 'OG001'}]}]}, {'title': 'Number of spotting only days', 'categories': [{'measurements': [{'value': '13.2', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '10.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 91 to Day 180', 'description': "The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.", 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the full analysis set who had an assessment for this evaluation'}, {'type': 'SECONDARY', 'title': 'Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1192', 'groupId': 'OG000'}, {'value': '1238', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro'}, {'id': 'OG001', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro'}], 'classes': [{'title': 'Number of bleeding/spotting days', 'categories': [{'measurements': [{'value': '19.4', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '16.3', 'spread': '12.8', 'groupId': 'OG001'}]}]}, {'title': 'Number of bleeding days', 'categories': [{'measurements': [{'value': '8.3', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '7.5', 'groupId': 'OG001'}]}]}, {'title': 'Number of spotting only days', 'categories': [{'measurements': [{'value': '11.2', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '10.0', 'spread': '8.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 181 to Day 270', 'description': "The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.", 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the full analysis set who had an assessment for this evaluation'}, {'type': 'SECONDARY', 'title': 'Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1123', 'groupId': 'OG000'}, {'value': '1175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro'}, {'id': 'OG001', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro'}], 'classes': [{'title': 'Number of bleeding/spotting days', 'categories': [{'measurements': [{'value': '17.6', 'spread': '12.1', 'groupId': 'OG000'}, {'value': '14.3', 'spread': '11.8', 'groupId': 'OG001'}]}]}, {'title': 'Number of bleeding days', 'categories': [{'measurements': [{'value': '7.2', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '6.6', 'groupId': 'OG001'}]}]}, {'title': 'Number of spotting only days', 'categories': [{'measurements': [{'value': '10.4', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '8.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 271 to Day 360', 'description': "The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.", 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the full analysis set who had an assessment for this evaluation'}, {'type': 'SECONDARY', 'title': 'Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '770', 'groupId': 'OG000'}, {'value': '819', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro'}, {'id': 'OG001', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro'}], 'classes': [{'title': 'Number of bleeding/spotting days', 'categories': [{'measurements': [{'value': '13.4', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '10.2', 'spread': '9.5', 'groupId': 'OG001'}]}]}, {'title': 'Number of bleeding days', 'categories': [{'measurements': [{'value': '4.8', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '5.3', 'groupId': 'OG001'}]}]}, {'title': 'Number of spotting only days', 'categories': [{'measurements': [{'value': '8.6', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '6.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 991 to Day 1080', 'description': "The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.", 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the full analysis set who had an assessment for this evaluation'}, {'type': 'SECONDARY', 'title': 'Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1355', 'groupId': 'OG000'}, {'value': '1376', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro'}, {'id': 'OG001', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro'}], 'classes': [{'title': 'Number of bleeding/spotting days', 'categories': [{'measurements': [{'value': '18.0', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '17.3', 'spread': '8.0', 'groupId': 'OG001'}]}]}, {'title': 'Number of bleeding days', 'categories': [{'measurements': [{'value': '8.2', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '6.3', 'groupId': 'OG001'}]}]}, {'title': 'Number of spotting only days', 'categories': [{'measurements': [{'value': '9.7', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '6.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to Day 30', 'description': "The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.", 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the full analysis set who had an assessment for this evaluation'}, {'type': 'SECONDARY', 'title': 'Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1345', 'groupId': 'OG000'}, {'value': '1375', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro'}, {'id': 'OG001', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro'}], 'classes': [{'title': 'Number of bleeding/spotting days', 'categories': [{'measurements': [{'value': '12.7', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '8.0', 'groupId': 'OG001'}]}]}, {'title': 'Number of bleeding days', 'categories': [{'measurements': [{'value': '5.6', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '5.3', 'groupId': 'OG001'}]}]}, {'title': 'Number of spotting only days', 'categories': [{'measurements': [{'value': '7.1', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '6.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 31 to Day 60', 'description': "The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.", 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the full analysis set who had an assessment for this evaluation'}, {'type': 'SECONDARY', 'title': 'Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1328', 'groupId': 'OG000'}, {'value': '1355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro'}, {'id': 'OG001', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro'}], 'classes': [{'title': 'Number of bleeding/spotting days', 'categories': [{'measurements': [{'value': '10.3', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '7.0', 'groupId': 'OG001'}]}]}, {'title': 'Number of bleeding days', 'categories': [{'measurements': [{'value': '4.4', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '4.5', 'groupId': 'OG001'}]}]}, {'title': 'Number of spotting only days', 'categories': [{'measurements': [{'value': '5.8', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '5.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 61 to Day 90', 'description': "The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.", 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the full analysis set who had an assessment for this evaluation'}, {'type': 'SECONDARY', 'title': 'Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1300', 'groupId': 'OG000'}, {'value': '1334', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro'}, {'id': 'OG001', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro'}], 'classes': [{'title': 'Number of bleeding/spotting days', 'categories': [{'measurements': [{'value': '8.6', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '6.2', 'groupId': 'OG001'}]}]}, {'title': 'Number of bleeding days', 'categories': [{'measurements': [{'value': '3.7', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '3.6', 'groupId': 'OG001'}]}]}, {'title': 'Number of spotting only days', 'categories': [{'measurements': [{'value': '4.9', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '4.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 91 to Day 120', 'description': "The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.", 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the full analysis set who had an assessment for this evaluation'}, {'type': 'SECONDARY', 'title': 'Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1130', 'groupId': 'OG000'}, {'value': '1186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro'}, {'id': 'OG001', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro'}], 'classes': [{'title': 'Number of bleeding/spotting days', 'categories': [{'measurements': [{'value': '5.7', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '4.4', 'groupId': 'OG001'}]}]}, {'title': 'Number of bleeding days', 'categories': [{'measurements': [{'value': '2.3', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Number of spotting only days', 'categories': [{'measurements': [{'value': '3.4', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 331 to Day 360', 'description': "The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.", 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the full analysis set who had an assessment for this evaluation'}, {'type': 'SECONDARY', 'title': 'Number of Participants With/Without Ovulation - Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro'}, {'id': 'OG001', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro'}], 'classes': [{'title': 'With ovulation', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Without ovulation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'For six weeks in the second half of Year 1', 'description': 'Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of women from the full analysis set'}, {'type': 'SECONDARY', 'title': 'Number of Participants With/Without Ovulation - Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro'}, {'id': 'OG001', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro'}], 'classes': [{'title': 'With ovulation', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Without ovulation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'For six weeks in the second half of Year 2', 'description': 'Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of women from the full analysis set'}, {'type': 'SECONDARY', 'title': 'Number of Participants With/Without Ovulation - Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro'}, {'id': 'OG001', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro'}], 'classes': [{'title': 'With ovulation', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Without ovulation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'For six weeks in the second half of Year 3', 'description': 'Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of women from the full analysis set'}, {'type': 'SECONDARY', 'title': 'Average Total Cervical Score - Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro'}, {'id': 'OG001', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro'}], 'classes': [{'categories': [{'measurements': [{'value': '3.067', 'spread': '1.291', 'groupId': 'OG000'}, {'value': '3.127', 'spread': '1.620', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'For six weeks in the second half of Year 1', 'description': 'Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus. Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of women from the full analysis set'}, {'type': 'SECONDARY', 'title': 'Average Total Cervical Score - Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro'}, {'id': 'OG001', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro'}], 'classes': [{'categories': [{'measurements': [{'value': '3.358', 'spread': '1.272', 'groupId': 'OG000'}, {'value': '2.798', 'spread': '1.499', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'For six weeks in the second half of Year 2', 'description': 'Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus.\n\nRange of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of women from the full analysis set'}, {'type': 'SECONDARY', 'title': 'Average Total Cervical Score - Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro'}, {'id': 'OG001', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro'}], 'classes': [{'categories': [{'measurements': [{'value': '2.837', 'spread': '1.354', 'groupId': 'OG000'}, {'value': '2.448', 'spread': '1.521', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'For six weeks in the second half of Year 3', 'description': 'Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus. Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of women from the full analysis set'}, {'type': 'SECONDARY', 'title': 'Classification of Endometrium - Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro'}, {'id': 'OG001', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro'}], 'classes': [{'title': 'Atrophic/inactive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Proliferative', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Secretory', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Menstrual', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Unclassified', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 1', 'description': 'The histological evaluation of the endometrium examined the effects of progesterone on the endometrium', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of women from the full analysis set'}, {'type': 'SECONDARY', 'title': 'Classification of Endometrium - Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro'}, {'id': 'OG001', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro'}], 'classes': [{'title': 'Atrophic/inactive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Proliferative', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Secretory', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Menstrual', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Unclassified', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 2', 'description': 'The histological evaluation of the endometrium examined the effects of progesterone on the endometrium', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of women from the full analysis set'}, {'type': 'SECONDARY', 'title': 'Classification of Endometrium - Year 3 / End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro'}, {'id': 'OG001', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro'}], 'classes': [{'title': 'Atrophic/inactive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Proliferative', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Secretory', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Menstrual', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Unclassified', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 3 / End of study', 'description': 'The histological evaluation of the endometrium examined the effects of progesterone on the endometrium', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of women from the full analysis set'}, {'type': 'SECONDARY', 'title': 'Degree of User Overall Satisfaction With Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1053', 'groupId': 'OG000'}, {'value': '1063', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro'}, {'id': 'OG001', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro'}], 'classes': [{'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Very satisfied', 'categories': [{'measurements': [{'value': '796', 'groupId': 'OG000'}, {'value': '842', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat satisfied', 'categories': [{'measurements': [{'value': '201', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}]}, {'title': 'Neither satisfied / dissatisfied', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Very dissatisfied', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the end of study/Year 3', 'description': 'Overall user satisfaction was assessed by a questionnaire given to participants at the end of the study. The questionnaire was only given to participants whose end-of-study visit occurred after implementation of Protocol Amendment 3.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the full analysis set who had an assessment for this evaluation'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Partial or Total Expulsion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1426', 'groupId': 'OG000'}, {'value': '1445', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro'}, {'id': 'OG001', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro'}], 'classes': [{'title': 'IUS partially expelled', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'IUS totally expelled', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 years', 'description': 'If LCS was displaced, but still in the cervical canal, it was assessed as being partially displaced. If LCS was expelled from the uterus, it was assessed as a total expulsion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the full analysis set who had an assessment for this evaluation'}, {'type': 'PRIMARY', 'title': 'Pearl Index for LCS16 up to 5 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1452', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro'}], 'classes': [{'categories': [{'measurements': [{'value': '0.29', 'groupId': 'OG000', 'lowerLimit': '0.16', 'upperLimit': '0.50'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'failure rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01445', 'ciLowerLimit': '0.00823', 'ciUpperLimit': '0.02531', 'groupDescription': 'Cumulative failure rate (Kaplan-Meier) at 5 years', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years', 'description': 'The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.', 'unitOfMeasure': 'Pregnancies per 100 women years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '617', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro'}], 'classes': [{'title': 'Number of bleeding/spotting days', 'categories': [{'measurements': [{'value': '9.6', 'spread': '9.0', 'groupId': 'OG000'}]}]}, {'title': 'Number of bleeding days', 'categories': [{'measurements': [{'value': '3.1', 'spread': '4.8', 'groupId': 'OG000'}]}]}, {'title': 'Number of spotting only days', 'categories': [{'measurements': [{'value': '6.6', 'spread': '6.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1081 to Day 1170', 'description': "The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.", 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the full analysis set who had an assessment for this evaluation'}, {'type': 'SECONDARY', 'title': 'Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '531', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro'}], 'classes': [{'title': 'Number of bleeding/spotting days', 'categories': [{'measurements': [{'value': '9.3', 'spread': '8.8', 'groupId': 'OG000'}]}]}, {'title': 'Number of bleeding days', 'categories': [{'measurements': [{'value': '2.9', 'spread': '4.9', 'groupId': 'OG000'}]}]}, {'title': 'Number of spotting only days', 'categories': [{'measurements': [{'value': '6.4', 'spread': '6.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1711 to Day 1800', 'description': "The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.", 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the full analysis set who had an assessment for this evaluation'}, {'type': 'SECONDARY', 'title': 'Degree of User Overall Satisfaction With Study Treatment up to 5 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '686', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro'}], 'classes': [{'title': 'Very satisfied', 'categories': [{'measurements': [{'value': '610', 'groupId': 'OG000'}]}]}, {'title': 'Somewhat satisfied', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'Neither satisfied / dissatisfied', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Very dissatisfied', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the end of study/Year 5', 'description': 'Overall user satisfaction was assessed by a questionnaire given to participants at the end of the study. The questionnaire was only given to participants whose end-of-study visit occurred after implementation of Protocol Amendment 3.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the full analysis set who participated in the extension phase and had an assessment for this evaluation'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Partial or Total Expulsion up to 5 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1445', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro'}], 'classes': [{'title': 'IUS partially expelled', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'IUS totally expelled', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years', 'description': 'If LCS was displaced, but still in the cervical canal, it was assessed as being partially displaced. If LCS was expelled from the uterus, it was assessed as a total expulsion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from the full analysis set who had an assessment for this evaluation'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LCS12', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro. Treatment up to 3 years.'}, {'id': 'FG001', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro. Treatment up to 5 years.'}], 'periods': [{'title': 'Treatment up to 3 Years', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1432'}, {'groupId': 'FG001', 'numSubjects': '1453'}]}, {'type': 'Participants Received Treatment', 'achievements': [{'comment': 'Full analysis set/Safety population', 'groupId': 'FG000', 'numSubjects': '1432'}, {'comment': 'Full analysis set/Safety population', 'groupId': 'FG001', 'numSubjects': '1452'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '819'}, {'groupId': 'FG001', 'numSubjects': '870'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '613'}, {'groupId': 'FG001', 'numSubjects': '583'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '313'}, {'groupId': 'FG001', 'numSubjects': '278'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '186'}, {'groupId': 'FG001', 'numSubjects': '186'}]}]}, {'title': 'Extension Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Only subjects in the LCS16 groups could participate in the extension phase', 'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '707'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '550'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '157'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1432', 'groupId': 'BG000'}, {'value': '1452', 'groupId': 'BG001'}, {'value': '2884', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LCS12', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro'}, {'id': 'BG001', 'title': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.2', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '35'}, {'value': '27.1', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '35'}, {'value': '27.1', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '35'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '≤ 25 years', 'categories': [{'measurements': [{'value': '566', 'groupId': 'BG000'}, {'value': '564', 'groupId': 'BG001'}, {'value': '1130', 'groupId': 'BG002'}]}]}, {'title': '> 25 years ≤ 35 years', 'categories': [{'measurements': [{'value': '866', 'groupId': 'BG000'}, {'value': '888', 'groupId': 'BG001'}, {'value': '1754', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1432', 'groupId': 'BG000'}, {'value': '1452', 'groupId': 'BG001'}, {'value': '2884', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2885}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-01', 'studyFirstSubmitDate': '2007-09-11', 'resultsFirstSubmitDate': '2012-07-11', 'studyFirstSubmitQcDate': '2007-09-11', 'lastUpdatePostDateStruct': {'date': '2017-01-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-22', 'studyFirstPostDateStruct': {'date': '2007-09-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pearl Index up to 3 Years', 'timeFrame': 'Up to 3 years', 'description': 'The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 3-year PI was obtained by dividing the number of pregnancies that occurred during the first three years of treatment by the time (in 100 women years) that the women were at risk of getting pregnant.'}, {'measure': 'Pearl Index for LCS16 up to 5 Years', 'timeFrame': 'Up to 5 years', 'description': 'The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.'}], 'secondaryOutcomes': [{'measure': 'Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 1', 'timeFrame': 'Day 1 to Day 90', 'description': "The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience."}, {'measure': 'Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 2', 'timeFrame': 'Day 91 to Day 180', 'description': "The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience."}, {'measure': 'Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 3', 'timeFrame': 'Day 181 to Day 270', 'description': "The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience."}, {'measure': 'Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 4', 'timeFrame': 'Day 271 to Day 360', 'description': "The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience."}, {'measure': 'Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 12', 'timeFrame': 'Day 991 to Day 1080', 'description': "The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience."}, {'measure': 'Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 1', 'timeFrame': 'Day 1 to Day 30', 'description': "The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience."}, {'measure': 'Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 2', 'timeFrame': 'Day 31 to Day 60', 'description': "The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience."}, {'measure': 'Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 3', 'timeFrame': 'Day 61 to Day 90', 'description': "The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience."}, {'measure': 'Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 4', 'timeFrame': 'Day 91 to Day 120', 'description': "The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience."}, {'measure': 'Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 12', 'timeFrame': 'Day 331 to Day 360', 'description': "The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience."}, {'measure': 'Number of Participants With/Without Ovulation - Year 1', 'timeFrame': 'For six weeks in the second half of Year 1', 'description': 'Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.'}, {'measure': 'Number of Participants With/Without Ovulation - Year 2', 'timeFrame': 'For six weeks in the second half of Year 2', 'description': 'Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.'}, {'measure': 'Number of Participants With/Without Ovulation - Year 3', 'timeFrame': 'For six weeks in the second half of Year 3', 'description': 'Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.'}, {'measure': 'Average Total Cervical Score - Year 1', 'timeFrame': 'For six weeks in the second half of Year 1', 'description': 'Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus. Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)'}, {'measure': 'Average Total Cervical Score - Year 2', 'timeFrame': 'For six weeks in the second half of Year 2', 'description': 'Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus.\n\nRange of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)'}, {'measure': 'Average Total Cervical Score - Year 3', 'timeFrame': 'For six weeks in the second half of Year 3', 'description': 'Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus. Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)'}, {'measure': 'Classification of Endometrium - Year 1', 'timeFrame': 'At Year 1', 'description': 'The histological evaluation of the endometrium examined the effects of progesterone on the endometrium'}, {'measure': 'Classification of Endometrium - Year 2', 'timeFrame': 'At Year 2', 'description': 'The histological evaluation of the endometrium examined the effects of progesterone on the endometrium'}, {'measure': 'Classification of Endometrium - Year 3 / End of Study', 'timeFrame': 'At Year 3 / End of study', 'description': 'The histological evaluation of the endometrium examined the effects of progesterone on the endometrium'}, {'measure': 'Degree of User Overall Satisfaction With Study Treatment', 'timeFrame': 'At the end of study/Year 3', 'description': 'Overall user satisfaction was assessed by a questionnaire given to participants at the end of the study. The questionnaire was only given to participants whose end-of-study visit occurred after implementation of Protocol Amendment 3.'}, {'measure': 'Number of Participants With Partial or Total Expulsion', 'timeFrame': 'Up to 3 years', 'description': 'If LCS was displaced, but still in the cervical canal, it was assessed as being partially displaced. If LCS was expelled from the uterus, it was assessed as a total expulsion.'}, {'measure': 'Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 13', 'timeFrame': 'Day 1081 to Day 1170', 'description': "The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience."}, {'measure': 'Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 20', 'timeFrame': 'Day 1711 to Day 1800', 'description': "The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience."}, {'measure': 'Degree of User Overall Satisfaction With Study Treatment up to 5 Years', 'timeFrame': 'At the end of study/Year 5', 'description': 'Overall user satisfaction was assessed by a questionnaire given to participants at the end of the study. The questionnaire was only given to participants whose end-of-study visit occurred after implementation of Protocol Amendment 3.'}, {'measure': 'Number of Participants With Partial or Total Expulsion up to 5 Years', 'timeFrame': 'Up to 5 years', 'description': 'If LCS was displaced, but still in the cervical canal, it was assessed as being partially displaced. If LCS was expelled from the uterus, it was assessed as a total expulsion.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contraception', 'Intrauterine', 'IUD', 'IUS'], 'conditions': ['Contraception']}, 'referencesModule': {'references': [{'pmid': '25661510', 'type': 'RESULT', 'citation': 'Nahum GG, Kaunitz AM, Rosen K, Schmelter T, Lynen R. Ovarian cysts: presence and persistence with use of a 13.5mg levonorgestrel-releasing intrauterine system. Contraception. 2015 May;91(5):412-7. doi: 10.1016/j.contraception.2015.01.021. Epub 2015 Feb 7.'}, {'pmid': '24726226', 'type': 'RESULT', 'citation': 'Apter D, Gemzell-Danielsson K, Hauck B, Rosen K, Zurth C. Pharmacokinetics of two low-dose levonorgestrel-releasing intrauterine systems and effects on ovulation rate and cervical function: pooled analyses of phase II and III studies. Fertil Steril. 2014 Jun;101(6):1656-62.e1-4. doi: 10.1016/j.fertnstert.2014.03.004. Epub 2014 Apr 14.'}, {'pmid': '24240244', 'type': 'RESULT', 'citation': 'Nelson A, Apter D, Hauck B, Schmelter T, Rybowski S, Rosen K, Gemzell-Danielsson K. Two low-dose levonorgestrel intrauterine contraceptive systems: a randomized controlled trial. Obstet Gynecol. 2013 Dec;122(6):1205-13. doi: 10.1097/AOG.0000000000000019.'}, {'pmid': '26378938', 'type': 'DERIVED', 'citation': 'Gemzell-Danielsson K, Apter D, Hauck B, Schmelter T, Rybowski S, Rosen K, Nelson A. The Effect of Age, Parity and Body Mass Index on the Efficacy, Safety, Placement and User Satisfaction Associated With Two Low-Dose Levonorgestrel Intrauterine Contraceptive Systems: Subgroup Analyses of Data From a Phase III Trial. PLoS One. 2015 Sep 17;10(9):e0135309. doi: 10.1371/journal.pone.0135309. eCollection 2015.'}], 'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu/', 'label': 'Click here to find information about studies related to Bayer Healthcare products conducted in Europe.'}]}, 'descriptionModule': {'briefSummary': 'This is a study on a new low dose levonorgestrel contraceptive intrauterine systems (LCS). The purpose of the study is to investigate which of the 2 administered doses is the lowest effective intrauterine dose of Levonorgestrel (LNG) administered via the LCS for contraception during 3 years. The study was amended: the LCS16 arm will be extended up to 5 years', 'detailedDescription': 'Drop out-rate will be covered in Participant flow section.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 35 years (inclusive), in good general health and requesting contraception.\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* History of ectopic pregnancies.\n* Any genital infection (until successfully treated).\n* Abnormal uterine bleeding of unknown origin.'}, 'identificationModule': {'nctId': 'NCT00528112', 'briefTitle': 'Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Multi-Center, Open-Label, Randomized Study to Assess the Safety and Contraceptive Efficacy of Two Doses ( in vitro12 µg/24h and 16 µg/24h) of the Ultra Low Dose Levonorgestrel Contraceptive Intrauterine Systems (LCS) for a Maximum of 3 Years in Women 18 to 35 Years of Age and an Extension Phase of the 16µg/24h Dose Group (LCS16 Arm) up to 5 Years', 'orgStudyIdInfo': {'id': '91665'}, 'secondaryIdInfos': [{'id': '310442', 'type': 'OTHER', 'domain': 'Company internal'}, {'id': 'G04209F', 'type': 'OTHER', 'domain': 'Company internal'}, {'id': 'G04209G', 'type': 'OTHER', 'domain': 'Company internal'}, {'id': '2007-000420-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LCS12', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro', 'interventionNames': ['Drug: LCS12']}, {'type': 'EXPERIMENTAL', 'label': 'LCS16', 'description': 'Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro', 'interventionNames': ['Drug: LCS16']}], 'interventions': [{'name': 'LCS12', 'type': 'DRUG', 'description': 'Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 12 microg/24 h', 'armGroupLabels': ['LCS12']}, {'name': 'LCS16', 'type': 'DRUG', 'description': 'Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 16 microg/24 h', 'armGroupLabels': ['LCS16']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85304', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United 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