Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT00266032
Status:
COMPLETED
Last Update Posted:
2014-11-03
First Post:
2005-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study on Safety and Efficacy of an Oral Contraceptive in Long Cycles
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C534342', 'term': 'drospirenone and ethinyl estradiol combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayerhealthcare.com', 'title': 'Therapeutic Area Head', 'organization': 'BAYER'}, 'certainAgreement': {'otherDetails': 'Bayer Schering Pharma (BSP AG) coordinates publishing of study results. Principal investigators (PIs) provide BSP AG with a draft at least 90 days prior to date of planned submission or presentation. BSP AG shall have 60 days to recommend any changes. BSP AG can prevent or delay publication by informing PIs within 60 days of BSP AG´s receipt of the document about to be published. PIs shall not publish press releases/other public statements about study/study drug without BSP AG´s written consent.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Data for center no. 1148 was included in "all randomized" set of subjects, but not in FAS, as during medical monitoring of laboratory data a suspicion of potential misconduct was found. An audit was made, but the suspicion could not be resolved.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.', 'otherNumAtRisk': 642, 'otherNumAffected': 310, 'seriousNumAtRisk': 642, 'seriousNumAffected': 19}, {'id': 'EG001', 'title': 'Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.', 'otherNumAtRisk': 209, 'otherNumAffected': 116, 'seriousNumAtRisk': 209, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.', 'otherNumAtRisk': 216, 'otherNumAffected': 121, 'seriousNumAtRisk': 216, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 82, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 31, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 28, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 34, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 18, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 52, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 25, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 19, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 21, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 22, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 46, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 32, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 20, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 38, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 29, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 213, 'numAffected': 129}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 62, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 83, 'numAffected': 53}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 22, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 36, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 21, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 168, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 62, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 76, 'numAffected': 48}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 41, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 22, 'numAffected': 15}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 17, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vulval abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Perineal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gynaecological chlamydia infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Postoperative thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Ligament rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Focal nodular hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cervix carcinoma stage 0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pelvic peritoneal adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nasal polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Rash generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Venous insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 642, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Days With Bleeding Including Spotting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '640', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.'}, {'id': 'OG001', 'title': 'Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.'}, {'id': 'OG002', 'title': 'Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'spread': '29', 'groupId': 'OG000'}, {'value': '61', 'spread': '51', 'groupId': 'OG001'}, {'value': '66', 'spread': '27', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-25', 'ciLowerLimit': '-29', 'ciUpperLimit': '-20', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '29', 'estimateComment': 'Mean of Yaz flexible regimen minus mean of Yaz standard was tested', 'groupDescription': 'Primary variable was tested for the hypothesis, whether the means are equal against the alternative (means are different) at a level of significance of alpha = 0.05 (t-test). For power calculation, a normal distribution, a absolute difference of 10 days, a Standard Deviation of 28 days and a drop-out rate of 40% was assumed.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'up to 1 year', 'description': 'The number of bleeding days per volunteer was calculated by summing up all days with bleeding intensity spotting or worse. The primary evaluation was the comparison of the flexible extended vs the standard regimen for this primary target variable, which was done for data within the first year of treatment only. As no further comparison or testing was done, no multiplicity issue arose.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) (reflecting Intention To Treat (ITT) population), all treated subjects with data available, no imputation'}, {'type': 'PRIMARY', 'title': 'Number of Unintended Pregnancies in Yaz Flexible Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '879', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 years', 'description': 'Pregnancies with conception date within 4 days after end of study medication were regarded as during treatment.', 'unitOfMeasure': 'pregnancies', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (reflecting ITT population), all treated subjects, no imputation, including switchers to flexible treatment in second year'}, {'type': 'PRIMARY', 'title': 'Pearl Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '879', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.64', 'groupId': 'OG000', 'lowerLimit': '0.28', 'upperLimit': '1.26'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 years', 'description': 'The Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 2-year PI was obtained by dividing the number of pregnancies that occurred during the two years of treatment by the time (in 100 women years) that the women were under risk of getting pregnant. 95% confidence interval according to European Medicine Agency Note for guidance on clinical investigation of steroid contraceptives in women.', 'unitOfMeasure': 'Pregnancies per 100 woman years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (reflecting ITT population), all treated subjects, no imputation, including switchers to flexible treatment in second year'}, {'type': 'PRIMARY', 'title': 'Number of Unintended Pregnancies Due to Method Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '875', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 years', 'description': 'Not included in this analysis are pregnancies due to subject failure eg. non-compliance with tablet intake rules.', 'unitOfMeasure': 'Pregnancies', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (reflecting ITT population), all treated subjects, no imputation, including switchers to flexible treatment in second year'}, {'type': 'PRIMARY', 'title': 'Adjusted Pearl Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '875', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.60', 'groupId': 'OG000', 'lowerLimit': '0.24', 'upperLimit': '1.24'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 years', 'description': 'The adjusted Pearl Index was based on pregnancies due to method failures and compliant treatment cycles, i.e. cycle length between 24 and 124 day, pill break not longer than 7 days, and number of pills taken not smaller than 90% of the number of days in that cycle minus 7 days.', 'unitOfMeasure': 'Pregnancies per 100 woman years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (reflecting ITT population), all treated subjects, no imputation, including switchers to flexible treatment in second year'}, {'type': 'SECONDARY', 'title': 'Number of Days With Bleeding Excluding Spotting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '640', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.'}, {'id': 'OG001', 'title': 'Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.'}, {'id': 'OG002', 'title': 'Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'spread': '15', 'groupId': 'OG000'}, {'value': '24', 'spread': '24', 'groupId': 'OG001'}, {'value': '43', 'spread': '20', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 1 year', 'description': 'The number of bleeding days per volunteer was calculated by summing up all days with bleeding intensity light, normal, or heavy.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Number of Bleeding Days During One Year of Treatment in Subjects With at Least 248 Days of Exposure Normalized to 372 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '563', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.'}, {'id': 'OG001', 'title': 'Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.'}, {'id': 'OG002', 'title': 'Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'spread': '29', 'groupId': 'OG000'}, {'value': '66', 'spread': '55', 'groupId': 'OG001'}, {'value': '71', 'spread': '24', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 1 year', 'description': 'For early dropouts and pregnant subjects with an exposure period of less than 1 year but at least 248 days, the number of bleeding/spotting days was normalized to correspond to a 1-year exposure period.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (reflecting ITT population), all treated subjects, no imputation'}, {'type': 'SECONDARY', 'title': 'Number of Bleeding / Spotting Days by 90-day Reference Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '605', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '203', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.'}, {'id': 'OG001', 'title': 'Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.'}, {'id': 'OG002', 'title': 'Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.'}], 'classes': [{'title': 'Reference period 1', 'categories': [{'measurements': [{'value': '7.2', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '8.6', 'groupId': 'OG001'}, {'value': '14.6', 'spread': '6.1', 'groupId': 'OG002'}]}]}, {'title': 'Reference period 2', 'categories': [{'measurements': [{'value': '5.3', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '6.5', 'groupId': 'OG001'}, {'value': '10.2', 'spread': '4.8', 'groupId': 'OG002'}]}]}, {'title': 'Reference period 3', 'categories': [{'measurements': [{'value': '4.6', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '5.8', 'groupId': 'OG001'}, {'value': '9.8', 'spread': '4.8', 'groupId': 'OG002'}]}]}, {'title': 'Reference period 4', 'categories': [{'measurements': [{'value': '3.9', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '5.6', 'groupId': 'OG001'}, {'value': '9.5', 'spread': '4.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 1 year', 'description': 'The mean number of bleeding / spotting days, spotting-only and bleeding days was analyzed using reference periods of 90 days as recommended by the WHO.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (reflecting ITT), all treated subjects, no imputation'}, {'type': 'SECONDARY', 'title': 'Number of Bleeding / Spotting Episodes in 90 Day Reference Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '605', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '203', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.'}, {'id': 'OG001', 'title': 'Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.'}, {'id': 'OG002', 'title': 'Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.'}], 'classes': [{'title': 'Reference period 1', 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'Reference period 2', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Reference period 3', 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Reference period 4', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '1.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to one year', 'description': 'The mean number of bleeding / spotting episodes was analyzed using reference periods of 90 days as recommended by the WHO.', 'unitOfMeasure': 'Episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (reflecting ITT), all treated subjects, no imputation'}, {'type': 'SECONDARY', 'title': 'Days With Scheduled Versus Unscheduled Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '640', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.'}, {'id': 'OG001', 'title': 'Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.'}], 'classes': [{'title': 'Scheduled bleeding', 'categories': [{'measurements': [{'value': '23.3', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '14.0', 'spread': '5.9', 'groupId': 'OG001'}]}]}, {'title': 'Unscheduled bleeding', 'categories': [{'measurements': [{'value': '17.1', 'spread': '17.4', 'groupId': 'OG000'}, {'value': '46.6', 'spread': '48.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to one year', 'description': 'Days with scheduled and unscheduled bleeding were evaluated for extended regimens only. Unscheduled is any bleeding/spotting that occurred while taking active hormones regardless of the duration of intake, unless they occurred after tablet-free interval during days 1-4 of subsequent treatment cycle, or unless they occurred during days 1-7 of first treatment cycle. Scheduled is any bleeding/spotting that occurred during tablet-free interval, regardless of duration of tablet intake, or during next 4 days of subsequent treatment cycle.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (reflecting ITT), all treated subjects, no imputation'}, {'type': 'POST_HOC', 'title': 'Number of Unintended Pregnancies Including Pregnancies Occuring Within 14 Days After End of Study Medication.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '639', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to one year', 'description': 'Pregnancies with conception date during treatment and within 14 days after end of study medication were included.', 'unitOfMeasure': 'Pregnancies', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'POST_HOC', 'title': 'Pearl Index (FDA Criteria)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '639', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.34', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '1.23'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to one year', 'description': 'Following an FDA request another PI evaluation was done for the first year of treatment only and taking into consideration also pregnancies with a conception date within 14 days after end of the study medication. Restricting the analysis to the required first year of treatment, it results in this PI estimation.', 'unitOfMeasure': 'Pregnancies per 100 woman years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.'}, {'id': 'FG001', 'title': 'Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.'}, {'id': 'FG002', 'title': 'Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.'}], 'periods': [{'title': 'Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'all randomized subjects, baseline data for full analysis set (FAS) only', 'groupId': 'FG000', 'numSubjects': '691'}, {'comment': 'all randomized subjects, baseline data for full analysis set (FAS) only', 'groupId': 'FG001', 'numSubjects': '236'}, {'comment': 'all randomized subjects, baseline data for full analysis set (FAS) only', 'groupId': 'FG002', 'numSubjects': '239'}]}, {'type': 'Patients Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '684'}, {'groupId': 'FG001', 'numSubjects': '221'}, {'groupId': 'FG002', 'numSubjects': '229'}]}, {'type': 'Patients Treated and in FAS', 'achievements': [{'comment': 'FAS', 'groupId': 'FG000', 'numSubjects': '642'}, {'comment': 'FAS', 'groupId': 'FG001', 'numSubjects': '209'}, {'comment': 'FAS', 'groupId': 'FG002', 'numSubjects': '216'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'not all entered period 2 (open-label safety extension)', 'groupId': 'FG000', 'numSubjects': '580'}, {'comment': 'not all entered period 2 (open-label safety extension)', 'groupId': 'FG001', 'numSubjects': '172'}, {'comment': 'not all entered period 2 (open-label safety extension)', 'groupId': 'FG002', 'numSubjects': '192'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '47'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'patient moved/wish for pregnancy/no need', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '8'}]}]}, {'title': 'Open-label Safety Extension', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'treatment for subjects of all 3 treatment groups in 2nd period, except for 28 in subgroups', 'groupId': 'FG000', 'numSubjects': '489'}, {'comment': '7 subjects continued their treatment in second period (safety extension)', 'groupId': 'FG001', 'numSubjects': '129'}, {'comment': '21 subjects continued their treatment in second period (safety extension)', 'groupId': 'FG002', 'numSubjects': '165'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '448'}, {'groupId': 'FG001', 'numSubjects': '115'}, {'groupId': 'FG002', 'numSubjects': '140'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'patient moved/wish for pregnancy/no need', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Randomization scheme in the subgroups was 1:1:1 for the 2 centers performing biopsies and measurements of Bone Mineral Density and metabolic parameters (82 subjects per treatment group). The remaining subjects were randomized according to the ratio 4:1:1.', 'preAssignmentDetails': '146 subjects failed screening, 96 of these 146 (65.8%) because inclusion or exclusion criteria were not met, 21 (14.4%) due to withdrawal of consent, 17 (11.6%) because of "other" reasons, 11 (7.5%) due to protocol deviations, 1 (0.7%) was lost to follow-up. 32 randomized subjects never took medication.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '642', 'groupId': 'BG000'}, {'value': '209', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}, {'value': '1067', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.'}, {'id': 'BG001', 'title': 'Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.'}, {'id': 'BG002', 'title': 'Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.8', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '35'}, {'value': '24.8', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '35'}, {'value': '24.3', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '35'}, {'value': '24.7', 'groupId': 'BG003', 'lowerLimit': '18', 'upperLimit': '35'}]}]}], 'paramType': 'MEAN', 'description': 'Number of Participants analyzed for baseline was Full Analysis Set (FAS=safety set)', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '642', 'groupId': 'BG000'}, {'value': '209', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}, {'value': '1067', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of Participants analyzed for baseline was Full Analysis Set (FAS=safety set)', 'unitOfMeasure': 'Participants'}, {'title': 'Body-Mass-Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '22.541', 'groupId': 'BG000', 'lowerLimit': '17.95', 'upperLimit': '30.50'}, {'value': '22.541', 'groupId': 'BG001', 'lowerLimit': '18.00', 'upperLimit': '29.70'}, {'value': '22.566', 'groupId': 'BG002', 'lowerLimit': '17.90', 'upperLimit': '29.80'}, {'value': '22.546', 'groupId': 'BG003', 'lowerLimit': '17.90', 'upperLimit': '30.50'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index was calculated with body weight and height measured at screening (BMI = body weight in kg²/ body height in m³) and had to be 18 Years to 35 Years old (smokers ≤ 30 Years old) at inclusion.\n\nNumber of Participants analyzed for baseline was Full Analysis Set (FAS=safety set).', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-27', 'studyFirstSubmitDate': '2005-12-14', 'resultsFirstSubmitDate': '2009-10-28', 'studyFirstSubmitQcDate': '2005-12-14', 'lastUpdatePostDateStruct': {'date': '2014-11-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-02-02', 'studyFirstPostDateStruct': {'date': '2005-12-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Days With Bleeding Including Spotting', 'timeFrame': 'up to 1 year', 'description': 'The number of bleeding days per volunteer was calculated by summing up all days with bleeding intensity spotting or worse. The primary evaluation was the comparison of the flexible extended vs the standard regimen for this primary target variable, which was done for data within the first year of treatment only. As no further comparison or testing was done, no multiplicity issue arose.'}, {'measure': 'Number of Unintended Pregnancies in Yaz Flexible Arm', 'timeFrame': 'up to 2 years', 'description': 'Pregnancies with conception date within 4 days after end of study medication were regarded as during treatment.'}, {'measure': 'Pearl Index', 'timeFrame': 'Up to 2 years', 'description': 'The Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 2-year PI was obtained by dividing the number of pregnancies that occurred during the two years of treatment by the time (in 100 women years) that the women were under risk of getting pregnant. 95% confidence interval according to European Medicine Agency Note for guidance on clinical investigation of steroid contraceptives in women.'}, {'measure': 'Number of Unintended Pregnancies Due to Method Failure', 'timeFrame': 'Up to 2 years', 'description': 'Not included in this analysis are pregnancies due to subject failure eg. non-compliance with tablet intake rules.'}, {'measure': 'Adjusted Pearl Index', 'timeFrame': 'Up to 2 years', 'description': 'The adjusted Pearl Index was based on pregnancies due to method failures and compliant treatment cycles, i.e. cycle length between 24 and 124 day, pill break not longer than 7 days, and number of pills taken not smaller than 90% of the number of days in that cycle minus 7 days.'}], 'secondaryOutcomes': [{'measure': 'Number of Days With Bleeding Excluding Spotting', 'timeFrame': 'up to 1 year', 'description': 'The number of bleeding days per volunteer was calculated by summing up all days with bleeding intensity light, normal, or heavy.'}, {'measure': 'Number of Bleeding Days During One Year of Treatment in Subjects With at Least 248 Days of Exposure Normalized to 372 Days', 'timeFrame': 'up to 1 year', 'description': 'For early dropouts and pregnant subjects with an exposure period of less than 1 year but at least 248 days, the number of bleeding/spotting days was normalized to correspond to a 1-year exposure period.'}, {'measure': 'Number of Bleeding / Spotting Days by 90-day Reference Period', 'timeFrame': 'up to 1 year', 'description': 'The mean number of bleeding / spotting days, spotting-only and bleeding days was analyzed using reference periods of 90 days as recommended by the WHO.'}, {'measure': 'Number of Bleeding / Spotting Episodes in 90 Day Reference Period', 'timeFrame': 'Up to one year', 'description': 'The mean number of bleeding / spotting episodes was analyzed using reference periods of 90 days as recommended by the WHO.'}, {'measure': 'Days With Scheduled Versus Unscheduled Bleeding', 'timeFrame': 'Up to one year', 'description': 'Days with scheduled and unscheduled bleeding were evaluated for extended regimens only. Unscheduled is any bleeding/spotting that occurred while taking active hormones regardless of the duration of intake, unless they occurred after tablet-free interval during days 1-4 of subsequent treatment cycle, or unless they occurred during days 1-7 of first treatment cycle. Scheduled is any bleeding/spotting that occurred during tablet-free interval, regardless of duration of tablet intake, or during next 4 days of subsequent treatment cycle.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Contraception']}, 'referencesModule': {'references': [{'pmid': '22454004', 'type': 'RESULT', 'citation': 'Klipping C, Duijkers I, Fortier MP, Marr J, Trummer D, Elliesen J. Long-term tolerability of ethinylestradiol 20 mug/drospirenone 3 mg in a flexible extended regimen: results from a randomised, controlled, multicentre study. J Fam Plann Reprod Health Care. 2012 Apr;38(2):84-93. doi: 10.1136/jfprhc-2011-100214.'}, {'pmid': '22454003', 'type': 'RESULT', 'citation': 'Klipping C, Duijkers I, Fortier MP, Marr J, Trummer D, Elliesen J. Contraceptive efficacy and tolerability of ethinylestradiol 20 mug/drospirenone 3 mg in a flexible extended regimen: an open-label, multicentre, randomised, controlled study. J Fam Plann Reprod Health Care. 2012 Apr;38(2):73-83. doi: 10.1136/jfprhc-2011-100213.'}, {'pmid': '23493606', 'type': 'RESULT', 'citation': 'Reif S, Snelder N, Blode H. Characterisation of the pharmacokinetics of ethinylestradiol and drospirenone in extended-cycle regimens: population pharmacokinetic analysis from a randomised Phase III study. J Fam Plann Reprod Health Care. 2013 Apr;39(2):e1-13. doi: 10.1136/jfprhc-2012-100397.'}], 'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu/', 'label': 'Click here to find information about studies related to Bayer Healthcare products conducted in Europe'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine safety and efficacy of long-cycle regimens of an oral contraceptive.', 'detailedDescription': 'The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG (BSP AG), Germany.\n\nBayer Schering Pharma AG, Germany is the sponsor of the trial.\n\nThe previously posted secondary Outcome Measure "Parameters of safety and tolerability" has been removed from result posting as it is covered by the Adverse Event section.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy women who desire contraception\n* smokers ≤ 30 Years old\n\nExclusion Criteria:\n\n* Contraindication against use of hormonal contraceptives'}, 'identificationModule': {'nctId': 'NCT00266032', 'briefTitle': 'Study on Safety and Efficacy of an Oral Contraceptive in Long Cycles', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Multicenter, Open, Randomized, Parallel Group Comparison to Assess the Safety and Efficacy of the Oral Contraceptive SH T00186D (0.02 mg Ethinylestradiol as Betadex Clathrate and 3 mg Drospirenone) in Two Variations of an Extended Regimen vs. a Standard Regimen (24 + 4 Days) in 1122 Healthy Female Volunteers for One Year, Followed by a One Year Safety Extension', 'orgStudyIdInfo': {'id': '91450'}, 'secondaryIdInfos': [{'id': '2005-002125-32', 'type': 'EUDRACT_NUMBER'}, {'id': '308683', 'type': 'OTHER', 'domain': 'Company Internal'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.', 'interventionNames': ['Drug: Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300)']}, {'type': 'EXPERIMENTAL', 'label': 'Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.', 'interventionNames': ['Drug: Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300)', 'description': '13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.', 'interventionNames': ['Drug: Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300)']}], 'interventions': [{'name': 'Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300)', 'type': 'DRUG', 'description': '3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. 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betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.', 'armGroupLabels': ['Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J2B 1H8', 'city': 'Drummondville', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.88336, 'lon': -72.48241}}, {'zip': 'H1T 1P6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H9R 4S3', 'city': 'Pointe-Claire', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.44868, 'lon': -73.81669}}, {'zip': 'G1S 2L6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'G9N 2H6', 'city': 'Shawinigan', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 46.56675, 'lon': -72.74913}}, {'zip': 'G1V 4X7', 'city': 'Ste-Foy', 'state': 'Quebec', 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'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12435', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13187', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '07545', 'city': 'Gera', 'state': 'Thuringia', 'country': 'Germany', 'geoPoint': {'lat': 50.88029, 'lon': 12.08187}}, {'zip': '07747', 'city': 'Jena', 'state': 'Thuringia', 'country': 'Germany', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '07768', 'city': 'Kahla', 'state': 'Thuringia', 'country': 'Germany', 'geoPoint': {'lat': 50.80651, 'lon': 11.58516}}, {'zip': '9713 GZ', 'city': 'Groningen', 'country': 'Netherlands', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}