Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-02-26 @ 6:28 AM
Study NCT ID:
NCT01508858
Status:
COMPLETED
Last Update Posted:
2017-01-24
First Post:
2012-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence on the Effect of an Oral Contraceptive Drug After Administration of Liraglutide in Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069450', 'term': 'Liraglutide'}, {'id': 'D016912', 'term': 'Levonorgestrel'}, {'id': 'D004997', 'term': 'Ethinyl Estradiol'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009644', 'term': 'Norgestrel'}, {'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D009651', 'term': 'Norpregnatrienes'}, {'id': 'D042782', 'term': 'Estrogenic Steroids, Alkylated'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-23', 'studyFirstSubmitDate': '2012-01-09', 'studyFirstSubmitQcDate': '2012-01-09', 'lastUpdatePostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC of ethinylestradiol'}, {'measure': 'AUC of levonorgestrel'}], 'secondaryOutcomes': [{'measure': 'AUC (0-t)'}, {'measure': 'Cmax, maximum concentration'}, {'measure': 'tmax, time to reach Cmax'}, {'measure': 't½, terminal half-life'}, {'measure': 'Adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '25504028', 'type': 'RESULT', 'citation': 'Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe. The aim of this trial is to investigate if liraglutide changes AUC (area under the curve) of ethinylestradiol and levonorgestrel administered as a combination contraceptive drug (Neovletta®).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal woman\n* Body Mass Index (BMI) between 18.0-30.0 kg/m\\^2 (both inclusive)\n* Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs, blood and urinary laboratory assessments\n\nExclusion Criteria:\n\n* History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the investigator\n* Impaired renal function\n* Active hepatitis B and/or active hepatitis C\n* Positive HIV (human immunodeficiency virus) antibodies\n* Known or suspected allergy to trial products or related products\n* Pregnant or positive pregnancy test at screening or nursing mother\n* Use of prescription or non-prescription medication within 2 weeks prior to first dosing with trial products which in the Investigators opinion will interfere with the pharmacokinetics of the compounds in Neovletta®\n* Use of hormone replacement therapy within 4 weeks prior to starting dosing with trial product\n* History of alcoholism or drug abuse\n* Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products\n* Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the Investigator\n* Excessive consumption of a diet deviating from a normal diet as judged by the Investigator'}, 'identificationModule': {'nctId': 'NCT01508858', 'briefTitle': 'Influence on the Effect of an Oral Contraceptive Drug After Administration of Liraglutide in Postmenopausal Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Double-blind, Two Period Cross-over, Single Centre Trial in Healthy Subjects Investigating the Influence on the Pharmacokinetics of Ethinylestradiol and Levonorgestrel in an Oral Contraceptive Drug After Multiple Dose Administration of Liraglutide', 'orgStudyIdInfo': {'id': 'NN2211-1330'}, 'secondaryIdInfos': [{'id': '2006-003904-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment period 1', 'interventionNames': ['Drug: liraglutide', 'Drug: placebo', 'Drug: levonorgestrel / ethinylestradiol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment period 2', 'interventionNames': ['Drug: liraglutide', 'Drug: placebo', 'Drug: levonorgestrel / ethinylestradiol']}], 'interventions': [{'name': 'liraglutide', 'type': 'DRUG', 'description': 'Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order', 'armGroupLabels': ['Treatment period 1', 'Treatment period 2']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order', 'armGroupLabels': ['Treatment period 1', 'Treatment period 2']}, {'name': 'levonorgestrel / ethinylestradiol', 'type': 'DRUG', 'description': 'One single oral tablet after the liraglutide or placebo dose administration at the end of each treatment period', 'armGroupLabels': ['Treatment period 1', 'Treatment period 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75323', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}