Viewing Study NCT00185458

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Ignite Creation Date: 2025-12-25 @ 12:16 AM
Ignite Modification Date: 2025-12-25 @ 10:18 PM
Study NCT ID: NCT00185458
Status: COMPLETED
Last Update Posted: 2013-11-27
First Post: 2005-09-13
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Assessment of the Transfer of Using Levonorgestrel Intrauterine System (LNG IUS) as a Contraceptive to Using it as Part of Hormone Replacement Therapy (HRT).
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayerhealthcare.com', 'title': 'Therapeutic Area Head', 'organization': 'BAYER'}, 'certainAgreement': {'otherDetails': 'The investigators agree to allow the sponsor to review any manuscripts and to negotiate the times and forums of their publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The data covers the entire treatment period (contraception phase + HRT phase).', 'eventGroups': [{'id': 'EG000', 'title': 'LNG IUS', 'description': 'Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.', 'otherNumAtRisk': 394, 'otherNumAffected': 357, 'seriousNumAtRisk': 394, 'seriousNumAffected': 25}], 'otherEvents': [{'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 117}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 59}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 47}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 43}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Menopausal symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 31}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 31}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Smear cervix normal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 31}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 29}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 28}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Breast tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 27}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 27}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 26}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 23}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 23}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 19}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Genital haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 19}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 18}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vaginitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 14}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 12}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cervical polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 9}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Breast cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 8}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vulvovaginal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 8}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bladder prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cholecystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Colpocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cystocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Jejunectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Muscle rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Periarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Scar excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Splenectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thyroidectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Varicose vein operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Volvulus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Bleeding Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}, {'value': '132', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Reference Period -1 (Contraception Phase)', 'description': 'Patient assessment within the last 90-days before starting the HRT'}, {'id': 'OG001', 'title': 'Reference Period 1 (HRT Phase)', 'description': 'Patient assessment within the first 90-days of the HRT phase'}, {'id': 'OG002', 'title': 'Reference Period 2 (HRT Phase)', 'description': 'Patient assessment within day 91 to 180 of the HRT phase'}, {'id': 'OG003', 'title': 'Reference Period 3 (HRT Phase)', 'description': 'Patient assessment within day 181 to 270 of the HRT phase'}, {'id': 'OG004', 'title': 'Reference Period 4 (HRT Phase)', 'description': 'Patient assessment within day 271 to 360 of the HRT phase'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'analyses': [{'pValue': '0.128', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': "Time effect tested with Friedman's two-way analysis of variance (ANOVA). The null-hypothesis is that the means are equal at the reference period tested.", 'statisticalMethod': "Friedman's two-way ANOVA", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Last 90 days in Contraception Phase and first 360 days in Hormone-Replacement Therapy (HRT) Phase', 'description': 'Measured by using Subject Diaries (Subject Reported Data)', 'unitOfMeasure': 'Bleeding days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population (ITT); all subjects with adequate bleeding diary data. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.'}, {'type': 'PRIMARY', 'title': 'Number of Spotting Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}, {'value': '132', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Reference Period -1 (Contraception Phase)', 'description': 'Patient assessment within the last 90-days before starting the HRT'}, {'id': 'OG001', 'title': 'Reference Period 1 (HRT Phase)', 'description': 'Patient assessment within the first 90-days of the HRT phase'}, {'id': 'OG002', 'title': 'Reference Period 2 (HRT Phase)', 'description': 'Patient assessment within day 91 to 180 of the HRT phase'}, {'id': 'OG003', 'title': 'Reference Period 3 (HRT Phase)', 'description': 'Patient assessment within day 181 to 270 of the HRT phase'}, {'id': 'OG004', 'title': 'Reference Period 4 (HRT Phase)', 'description': 'Patient assessment within day 271 to 360 of the HRT phase'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '11'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '1', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '6'}]}]}], 'analyses': [{'pValue': '0.296', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': "Time effect tested with Friedman's two-way analysis of variance (ANOVA). The null-hypothesis is that the means are equal at the reference period tested.", 'statisticalMethod': "Friedman's two-way ANOVA", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Last 90 days in Contraception Phase and first 360 days in HRT Phase', 'description': 'Measured by using Subject Diaries (Subject Reported Data)', 'unitOfMeasure': 'Spotting days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; all subjects with adequate bleeding diary data. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Successful Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LNG IUS', 'description': 'Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Last 90 days in Contraception Phase and first 360 days in HRT Phase', 'description': 'Definition of successful treatment:\n\n* Completion of HRT phase, and\n* Both, the number of bleeding days and the number of spotting days during HRT was equal to or less than during contraceptive phase, and\n* The number of bleeding days and the number of spotting days could be calculated for at least 3 out of the first 4 reference periods in HRT', 'unitOfMeasure': 'Percentage of participants with success', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; all subjects eligible for the HRT'}, {'type': 'SECONDARY', 'title': "Assessment of QOL as Measured by Women's Health Questionnaire", 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Last Measurement Before Start of HRT Phase', 'description': 'Patient assessment at the end of contraception phase'}, {'id': 'OG001', 'title': '6 Months After Start of HRT Phase', 'description': 'Patient assessment about day 180 of the HRT phase'}, {'id': 'OG002', 'title': '12 Months After Start of HRT Phase', 'description': 'Patient assessment about day 360 of the HRT phase'}], 'classes': [{'categories': [{'measurements': [{'value': '104.1', 'spread': '17.75', 'groupId': 'OG000'}, {'value': '114.4', 'spread': '16.64', 'groupId': 'OG001'}, {'value': '112.9', 'spread': '16.32', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': "This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.", 'statisticalMethod': "Friedman's two-way ANOVA", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': "Women's Health Questionnaire (Total Score). For the Total score, the minimum is 36 and maximum is 144. A higher score means the distress and dysfunction are less pronounced.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.'}, {'type': 'SECONDARY', 'title': 'Continuation Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '394', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LNG IUS', 'description': 'Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.'}], 'classes': [{'title': 'At Entry', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'At 2 Years', 'categories': [{'measurements': [{'value': '72.3', 'groupId': 'OG000'}]}]}, {'title': 'At 4 Years', 'categories': [{'measurements': [{'value': '23.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At entry, at 2 years, at 4 years', 'description': 'Percentage of subjects continuing in the study at the given time points.', 'unitOfMeasure': 'Percentage of participants continuing', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Kaplan-Meier estimator given.'}, {'type': 'SECONDARY', 'title': 'Progestogenic Symptom 1: Headache (as Measured by a Visual Analogue Scale (VAS))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Last Measurement Before Start of HRT Phase', 'description': 'Patient assessment at the end of contraception phase'}, {'id': 'OG001', 'title': '6 Months After Start of HRT Phase', 'description': 'Patient assessment about day 180 of the HRT phase'}, {'id': 'OG002', 'title': '12 Months After Start of HRT Phase', 'description': 'Patient assessment about day 360 of the HRT phase'}], 'classes': [{'categories': [{'measurements': [{'value': '23.9', 'spread': '23.98', 'groupId': 'OG000'}, {'value': '19.1', 'spread': '22.57', 'groupId': 'OG001'}, {'value': '18.2', 'spread': '23.00', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.027', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': "This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.", 'statisticalMethod': "Friedman's two-way ANOVA", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.'}, {'type': 'SECONDARY', 'title': 'Progestogenic Symptom 2: Depressive Mood (as Measured by a VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Last Measurement Before Start of HRT Phase', 'description': 'Patient assessment at the end of contraception phase'}, {'id': 'OG001', 'title': '6 Months After Start of HRT Phase', 'description': 'Patient assessment about day 180 of the HRT phase'}, {'id': 'OG002', 'title': '12 Months After Start of HRT Phase', 'description': 'Patient assessment about day 360 of the HRT phase'}], 'classes': [{'categories': [{'measurements': [{'value': '22.3', 'spread': '25.69', 'groupId': 'OG000'}, {'value': '11.8', 'spread': '17.31', 'groupId': 'OG001'}, {'value': '14.6', 'spread': '22.10', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': "This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.", 'statisticalMethod': "Friedman's two-way ANOVA", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.'}, {'type': 'SECONDARY', 'title': 'Progestogenic Symptom 3: Acne or Greasy Skin (as Measured by a VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Last Measurement Before Start of HRT Phase', 'description': 'Patient assessment at the end of contraception phase'}, {'id': 'OG001', 'title': '6 Months After Start of HRT Phase', 'description': 'Patient assessment about day 180 of the HRT phase'}, {'id': 'OG002', 'title': '12 Months After Start of HRT Phase', 'description': 'Patient assessment about day 360 of the HRT phase'}], 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'spread': '14.02', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '15.38', 'groupId': 'OG001'}, {'value': '7.6', 'spread': '15.41', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': "This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.", 'statisticalMethod': "Friedman's two-way ANOVA", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.'}, {'type': 'SECONDARY', 'title': 'Progestogenic Symptom 4: Nausea (as Measured by a VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Last Measurement Before Start of HRT Phase', 'description': 'Patient assessment at the end of contraception phase'}, {'id': 'OG001', 'title': '6 Months After Start of HRT Phase', 'description': 'Patient assessment about day 180 of the HRT phase'}, {'id': 'OG002', 'title': '12 Months After Start of HRT Phase', 'description': 'Patient assessment about day 360 of the HRT phase'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'spread': '13.57', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '11.96', 'groupId': 'OG001'}, {'value': '6.7', 'spread': '15.32', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': "This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.", 'statisticalMethod': "Friedman's two-way ANOVA", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.'}, {'type': 'SECONDARY', 'title': 'Progestogenic Symptom 5: Edema (as Measured by a VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Last Measurement Before Start of HRT Phase', 'description': 'Patient assessment at the end of contraception phase'}, {'id': 'OG001', 'title': '6 Months After Start of HRT Phase', 'description': 'Patient assessment about day 180 of the HRT phase'}, {'id': 'OG002', 'title': '12 Months After Start of HRT Phase', 'description': 'Patient assessment about day 360 of the HRT phase'}], 'classes': [{'categories': [{'measurements': [{'value': '15.7', 'spread': '20.30', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '18.93', 'groupId': 'OG001'}, {'value': '11.7', 'spread': '17.65', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.054', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': "This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.", 'statisticalMethod': "Friedman's two-way ANOVA", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.'}, {'type': 'SECONDARY', 'title': 'Progestogenic Symptom 6: Decreased Libido (as Measured by a VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Last Measurement Before Start of HRT Phase', 'description': 'Patient assessment at the end of contraception phase'}, {'id': 'OG001', 'title': '6 Months After Start of HRT Phase', 'description': 'Patient assessment about day 180 of the HRT phase'}, {'id': 'OG002', 'title': '12 Months After Start of HRT Phase', 'description': 'Patient assessment about day 360 of the HRT phase'}], 'classes': [{'categories': [{'measurements': [{'value': '24.9', 'spread': '26.29', 'groupId': 'OG000'}, {'value': '15.6', 'spread': '22.06', 'groupId': 'OG001'}, {'value': '17.5', 'spread': '21.13', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': "This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.", 'statisticalMethod': "Friedman's two-way ANOVA", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.'}, {'type': 'SECONDARY', 'title': 'Climacteric Symptom 1: Hot Flushes (as Measured by a VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Last Measurement Before Start of HRT Phase', 'description': 'Patient assessment at the end of contraception phase'}, {'id': 'OG001', 'title': '6 Months After Start of HRT Phase', 'description': 'Patient assessment about day 180 of the HRT phase'}, {'id': 'OG002', 'title': '12 Months After Start of HRT Phase', 'description': 'Patient assessment about day 360 of the HRT phase'}], 'classes': [{'categories': [{'measurements': [{'value': '39.9', 'spread': '30.21', 'groupId': 'OG000'}, {'value': '9.4', 'spread': '14.88', 'groupId': 'OG001'}, {'value': '11.3', 'spread': '18.65', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': "This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.", 'statisticalMethod': "Friedman's two-way ANOVA", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.'}, {'type': 'SECONDARY', 'title': 'Climacteric Symptom 2: Sweating Episodes (as Measured by a VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Last Measurement Before Start of HRT Phase', 'description': 'Patient assessment at the end of contraception phase'}, {'id': 'OG001', 'title': '6 Months After Start of HRT Phase', 'description': 'Patient assessment about day 180 of the HRT phase'}, {'id': 'OG002', 'title': '12 Months After Start of HRT Phase', 'description': 'Patient assessment about day 360 of the HRT phase'}], 'classes': [{'categories': [{'measurements': [{'value': '43.0', 'spread': '29.40', 'groupId': 'OG000'}, {'value': '14.0', 'spread': '19.95', 'groupId': 'OG001'}, {'value': '17.0', 'spread': '21.97', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': "This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.", 'statisticalMethod': "Friedman's two-way ANOVA", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.'}, {'type': 'SECONDARY', 'title': 'Climacteric Symptom 3: Vaginal Dryness (as Measured by a VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Last Measurement Before Start of HRT Phase', 'description': 'Patient assessment at the end of contraception phase'}, {'id': 'OG001', 'title': '6 Months After Start of HRT Phase', 'description': 'Patient assessment about day 180 of the HRT phase'}, {'id': 'OG002', 'title': '12 Months After Start of HRT Phase', 'description': 'Patient assessment about day 360 of the HRT phase'}], 'classes': [{'categories': [{'measurements': [{'value': '22.8', 'spread': '27.96', 'groupId': 'OG000'}, {'value': '13.1', 'spread': '20.93', 'groupId': 'OG001'}, {'value': '16.7', 'spread': '23.00', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': "This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.", 'statisticalMethod': "Friedman's two-way ANOVA", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.'}, {'type': 'SECONDARY', 'title': 'Climacteric Symptom 4: Sleep Problems (as Measured by a VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Last Measurement Before Start of HRT Phase', 'description': 'Patient assessment at the end of contraception phase'}, {'id': 'OG001', 'title': '6 Months After Start of HRT Phase', 'description': 'Patient assessment about day 180 of the HRT phase'}, {'id': 'OG002', 'title': '12 Months After Start of HRT Phase', 'description': 'Patient assessment about day 360 of the HRT phase'}], 'classes': [{'categories': [{'measurements': [{'value': '39.4', 'spread': '29.71', 'groupId': 'OG000'}, {'value': '17.1', 'spread': '21.34', 'groupId': 'OG001'}, {'value': '19.9', 'spread': '23.93', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': "This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.", 'statisticalMethod': "Friedman's two-way ANOVA", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.'}, {'type': 'SECONDARY', 'title': 'Climacteric Symptom 5: Irritability (as Measured by a VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Last Measurement Before Start of HRT Phase', 'description': 'Patient assessment at the end of contraception phase'}, {'id': 'OG001', 'title': '6 Months After Start of HRT Phase', 'description': 'Patient assessment about day 180 of the HRT phase'}, {'id': 'OG002', 'title': '12 Months After Start of HRT Phase', 'description': 'Patient assessment about day 360 of the HRT phase'}], 'classes': [{'categories': [{'measurements': [{'value': '33.1', 'spread': '27.40', 'groupId': 'OG000'}, {'value': '17.2', 'spread': '19.47', 'groupId': 'OG001'}, {'value': '19.4', 'spread': '20.26', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': "This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.", 'statisticalMethod': "Friedman's two-way ANOVA", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.'}, {'type': 'SECONDARY', 'title': 'Climacteric Symptom 6: Breast Tension (as Measured by a VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Last Measurement Before Start of HRT Phase', 'description': 'Patient assessment at the end of contraception phase'}, {'id': 'OG001', 'title': '6 Months After Start of HRT Phase', 'description': 'Patient assessment about day 180 of the HRT phase'}, {'id': 'OG002', 'title': '12 Months After Start of HRT Phase', 'description': 'Patient assessment about day 360 of the HRT phase'}], 'classes': [{'categories': [{'measurements': [{'value': '15.5', 'spread': '22.16', 'groupId': 'OG000'}, {'value': '13.5', 'spread': '20.39', 'groupId': 'OG001'}, {'value': '13.0', 'spread': '19.42', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.175', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': "This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.", 'statisticalMethod': "Friedman's two-way ANOVA", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.'}, {'type': 'SECONDARY', 'title': 'Progestogenic Symptom 7: Hair Loss (as Measured by a VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Last Measurement Before Start of HRT Phase', 'description': 'Patient assessment at the end of contraception phase'}, {'id': 'OG001', 'title': '6 Months After Start of HRT Phase', 'description': 'Patient assessment about day 180 of the HRT phase'}, {'id': 'OG002', 'title': '12 Months After Start of HRT Phase', 'description': 'Patient assessment about day 360 of the HRT phase'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'spread': '15.14', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '16.69', 'groupId': 'OG001'}, {'value': '9.0', 'spread': '13.63', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.062', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': "This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.", 'statisticalMethod': "Friedman's two-way ANOVA", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.'}, {'type': 'SECONDARY', 'title': 'Progestogenic Symptom 8: Greasy Hair (as Measured by a VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Last Measurement Before Start of HRT Phase', 'description': 'Patient assessment at the end of contraception phase'}, {'id': 'OG001', 'title': '6 Months After Start of HRT Phase', 'description': 'Patient assessment about day 180 of the HRT phase'}, {'id': 'OG002', 'title': '12 Months After Start of HRT Phase', 'description': 'Patient assessment about day 360 of the HRT phase'}], 'classes': [{'categories': [{'measurements': [{'value': '14.0', 'spread': '20.60', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '18.85', 'groupId': 'OG001'}, {'value': '11.1', 'spread': '18.93', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': "This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.", 'statisticalMethod': "Friedman's two-way ANOVA", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LNG IUS', 'description': 'Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.'}], 'periods': [{'title': 'Contraception Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '394'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '336'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}, {'title': 'HRT Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '168 subjects were eligible for the HRT phase out 336 who completed contraception phase.', 'groupId': 'FG000', 'numSubjects': '168'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Only the subjects who reached menopause within max. of 4 years of the contraception phase were eligible for the Hormone-Replacement Therapy (HRT) phase. 58 subjects discontinued the study during the contraception phase before starting the HRT, and 168 subjects who started treatment did not reach menopause.', 'preAssignmentDetails': '489 subjects were screened: 394 subjects started treatment and 95 subjects failed screening. Intent-to-treat (ITT) population included all subjects (N=394) who had the LNG IUS inserted, or for whom the insertion was attempted. 322 subjects without major protocol deviations were included in the Per protocol set (PPS).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '394', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'LNG IUS', 'description': 'Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.8', 'spread': '1.42', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '394', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 394}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-05', 'studyFirstSubmitDate': '2005-09-13', 'resultsFirstSubmitDate': '2009-07-23', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-10-12', 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Bleeding Days', 'timeFrame': 'Last 90 days in Contraception Phase and first 360 days in Hormone-Replacement Therapy (HRT) Phase', 'description': 'Measured by using Subject Diaries (Subject Reported Data)'}, {'measure': 'Number of Spotting Days', 'timeFrame': 'Last 90 days in Contraception Phase and first 360 days in HRT Phase', 'description': 'Measured by using Subject Diaries (Subject Reported Data)'}, {'measure': 'Percentage of Participants With Successful Treatment', 'timeFrame': 'Last 90 days in Contraception Phase and first 360 days in HRT Phase', 'description': 'Definition of successful treatment:\n\n* Completion of HRT phase, and\n* Both, the number of bleeding days and the number of spotting days during HRT was equal to or less than during contraceptive phase, and\n* The number of bleeding days and the number of spotting days could be calculated for at least 3 out of the first 4 reference periods in HRT'}], 'secondaryOutcomes': [{'measure': "Assessment of QOL as Measured by Women's Health Questionnaire", 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': "Women's Health Questionnaire (Total Score). For the Total score, the minimum is 36 and maximum is 144. A higher score means the distress and dysfunction are less pronounced."}, {'measure': 'Continuation Rates', 'timeFrame': 'At entry, at 2 years, at 4 years', 'description': 'Percentage of subjects continuing in the study at the given time points.'}, {'measure': 'Progestogenic Symptom 1: Headache (as Measured by a Visual Analogue Scale (VAS))', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.'}, {'measure': 'Progestogenic Symptom 2: Depressive Mood (as Measured by a VAS)', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.'}, {'measure': 'Progestogenic Symptom 3: Acne or Greasy Skin (as Measured by a VAS)', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.'}, {'measure': 'Progestogenic Symptom 4: Nausea (as Measured by a VAS)', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.'}, {'measure': 'Progestogenic Symptom 5: Edema (as Measured by a VAS)', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.'}, {'measure': 'Progestogenic Symptom 6: Decreased Libido (as Measured by a VAS)', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.'}, {'measure': 'Climacteric Symptom 1: Hot Flushes (as Measured by a VAS)', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.'}, {'measure': 'Climacteric Symptom 2: Sweating Episodes (as Measured by a VAS)', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.'}, {'measure': 'Climacteric Symptom 3: Vaginal Dryness (as Measured by a VAS)', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.'}, {'measure': 'Climacteric Symptom 4: Sleep Problems (as Measured by a VAS)', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.'}, {'measure': 'Climacteric Symptom 5: Irritability (as Measured by a VAS)', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.'}, {'measure': 'Climacteric Symptom 6: Breast Tension (as Measured by a VAS)', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.'}, {'measure': 'Progestogenic Symptom 7: Hair Loss (as Measured by a VAS)', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.'}, {'measure': 'Progestogenic Symptom 8: Greasy Hair (as Measured by a VAS)', 'timeFrame': 'Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase', 'description': 'Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Menopause']}, 'referencesModule': {'references': [{'pmid': '20888118', 'type': 'RESULT', 'citation': 'Depypere HT, Hillard T, Erkkola R, Lukkari-Lax E, Kunz M, Rautiainen P, Schram JH. A 60-month non-comparative study on bleeding profiles with the levonorgestrel intrauterine system from the late transition period to estrogen supplemented menopause. Eur J Obstet Gynecol Reprod Biol. 2010 Dec;153(2):176-80. doi: 10.1016/j.ejogrb.2010.08.017.'}]}, 'descriptionModule': {'briefSummary': 'The study has been designed to look at the transfer from using LNG IUS for contraception only, in reproductive age to using it for endometrial protection in menopausal age. The main area of interest in the study is the pattern of any vaginal bleeding that occurs.', 'detailedDescription': 'The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '51 Years', 'minimumAge': '46 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with intact uterus, regular menstrual cycles and no previous or current climacteric symptoms.\n\nExclusion Criteria:\n\n* Pregnancy or lactation.\n* Previous pelvic infections.\n* Abnormal bleeding.\n* Abnormal uterine cavity.\n* Uterine polyps.\n* Genital cancer.\n* Liver diseases.\n* Alcoholism or drug abuse.'}, 'identificationModule': {'nctId': 'NCT00185458', 'briefTitle': 'Assessment of the Transfer of Using Levonorgestrel Intrauterine System (LNG IUS) as a Contraceptive to Using it as Part of Hormone Replacement Therapy (HRT).', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A 60-month Non-comparative Study on Bleeding Profiles With Levonorgestrel Intrauterine System in Transition From Reproductive Age Contraception to Menopause Age Endometrial Protection During Estrogen Replacement Therapy.', 'orgStudyIdInfo': {'id': '90660'}, 'secondaryIdInfos': [{'id': '300400', 'type': 'OTHER', 'domain': 'Company Internal'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LNG IUS', 'description': 'Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.', 'interventionNames': ['Drug: LNG IUS']}], 'interventions': [{'name': 'LNG IUS', 'type': 'DRUG', 'description': 'LNG IUS (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) HRT Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by WHO guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.', 'armGroupLabels': ['LNG IUS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '4500', 'city': 'Huy', 'country': 'Belgium', 'geoPoint': {'lat': 50.51894, 'lon': 5.23284}}, {'zip': '02100', 'city': 'Espoo', 'country': 'Finland', 'geoPoint': {'lat': 60.2052, 'lon': 24.6522}}, {'zip': '20100', 'city': 'Turku', 'country': 'Finland', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '20520', 'city': 'Turku', 'country': 'Finland', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '6419 PC', 'city': 'Heerlen', 'country': 'Netherlands', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}, {'zip': '5912 BL', 'city': 'Venlo', 'country': 'Netherlands', 'geoPoint': {'lat': 51.37, 'lon': 6.16806}}, {'zip': '1502 DV', 'city': 'Zaandam', 'country': 'Netherlands', 'geoPoint': {'lat': 52.43854, 'lon': 4.82643}}, {'zip': '3331 LZ', 'city': 'Zwijndrecht', 'country': 'Netherlands', 'geoPoint': {'lat': 51.8175, 'lon': 4.63333}}, {'zip': 'CB23 2TN', 'city': 'Cambridge', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'BH15 2JB', 'city': 'Poole', 'state': 'Dorset', 'country': 'United Kingdom', 'geoPoint': {'lat': 50.71429, 'lon': -1.98458}}, {'zip': 'NE4 6BE', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}