Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-02-01 @ 10:11 PM
Study NCT ID:
NCT01073904
Status:
COMPLETED
Last Update Posted:
2014-04-03
First Post:
2010-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel 1.5 mg
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-01', 'studyFirstSubmitDate': '2010-02-22', 'studyFirstSubmitQcDate': '2010-02-22', 'lastUpdatePostDateStruct': {'date': '2014-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Least square estimator of average maximum plasmatic concentration (log transformed)', 'timeFrame': 'After 2 months'}, {'measure': 'Least square estimator of area under the pharmacokinetic curve (log transformed)', 'timeFrame': 'After 2 months'}], 'secondaryOutcomes': [{'measure': 'Time at which maximum concentration is reached', 'timeFrame': 'After 2 months'}, {'measure': 'Area under the pharmacokinetic curve from time=0 to last blood sample', 'timeFrame': 'After 2 months'}, {'measure': 'Half life of plasmatic concentration of study drug', 'timeFrame': 'After 2 months'}, {'measure': 'Clearance constant of plasmatic concentration of study drug', 'timeFrame': 'After 2 months'}, {'measure': 'Adverse events collection', 'timeFrame': 'Up to 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Contraceptives, Postcoital']}, 'descriptionModule': {'briefSummary': 'A single dose, two treatments (Postinor-2 and Opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 14 days between the two study periods. Treatment groups are balanced with the same number of male healthy volunteers who were randomly assigned to the study drug administration sequences.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis.\n\nExclusion Criteria:\n\n* History of illnesses or any organic abnormalities that could affect the results of the study.\n* History of tobacco or alcohol abuse or regular use of recreational or therapeutic drugs.\n* Subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup.'}, 'identificationModule': {'nctId': 'NCT01073904', 'acronym': 'LEVEQ-3', 'briefTitle': 'Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel 1.5 mg', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Open-label, Randomized, Crossover Study to Prove the Bioequivalence Between Opxion® (Levonorgestrel 1.5 mg Coated Tablet From Bayer de Mexico) and Postinor 2® (Levonorgestrel 1.5 mg Tablet From Biofarma Natural CMD) in Healthy Volunteers', 'orgStudyIdInfo': {'id': '14782'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Levonorgestrel Emergency Pill (BAY86-5028)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'interventionNames': ['Drug: Postinor 2']}], 'interventions': [{'name': 'Levonorgestrel Emergency Pill (BAY86-5028)', 'type': 'DRUG', 'description': 'Single dose of 1.5 mg coated tablet', 'armGroupLabels': ['Arm 1']}, {'name': 'Postinor 2', 'type': 'DRUG', 'description': 'Single dose of 1.5 mg tablet', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58256', 'city': 'Morelia', 'state': 'Michoacán', 'country': 'Mexico', 'geoPoint': {'lat': 19.70078, 'lon': -101.18443}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}