Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT01044056
Status:
COMPLETED
Last Update Posted:
2022-02-04
First Post:
2010-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Trial in Healthy Female Subjects to Compare the Pharmacokinetics of Ethinyl Estradiol of NuvaRing®, a Contraceptive Patch (EVRA(TM)) and an Oral Contraceptive (Microgynon® 30) (Study 34237 (P06650)) (COMPLETED)
Sponsor:
Organization:
Raw JSON
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Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.'}, {'id': 'OG002', 'title': 'Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring', 'description': 'NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.9', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '35.8', 'spread': '5.5', 'groupId': 'OG001'}, {'value': '10.6', 'spread': '2.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '21 days', 'description': 'AUC 0-21 days was measured using ethinylestradiol serum concentration using a radio-immune assay at several time points during the 21 days of active treatment', 'unitOfMeasure': 'nh.h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received at least one dose of medication.'}, {'type': 'PRIMARY', 'title': 'AUC 0-tlast (PK Parameter) for the ASPE Group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill', 'description': 'Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.'}, {'id': 'OG001', 'title': 'Norelgestrominum and Ethinylestradiol Contraceptive Patch', 'description': 'A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.'}, {'id': 'OG002', 'title': 'Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring', 'description': 'NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.5', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '37.5', 'spread': '5.7', 'groupId': 'OG001'}, {'value': '11.1', 'spread': '2.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '21 days of active treatment and washout period thereafter', 'description': 'AUC 0-tlast was measured using ethinylestradiol serum concentrations using a radio-immune assay at several time points during the 21 days of active treatment and the washout period thereafter.', 'unitOfMeasure': 'ng.h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received at least one dose of medication.'}, {'type': 'PRIMARY', 'title': 'AUC 0-infinity (PK Parameter) for the ASPE Group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill', 'description': 'Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.'}, {'id': 'OG001', 'title': 'Norelgestrominum and Ethinylestradiol Contraceptive Patch', 'description': 'A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.'}, {'id': 'OG002', 'title': 'Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring', 'description': 'NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.7', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '37.7', 'spread': '5.6', 'groupId': 'OG001'}, {'value': '11.2', 'spread': '2.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '21 days of active treatment and the washout period thereafter', 'description': 'AUC 0-infinity was measured using ethinylestradiol serum concentration using a radio-immune assay at several time points during the 21 days of active treatment and the washout period thereafter. AUC 0-infinity was calculated as AUC 0-tlast extrapolated to infinity using the regression line from which t 1/2 was calculated.', 'unitOfMeasure': 'ng.h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill', 'description': 'Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.'}, {'id': 'FG001', 'title': 'Norelgestrominum and Ethinylestradiol Contraceptive Patch', 'description': 'A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.'}, {'id': 'FG002', 'title': 'Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring', 'description': 'NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill', 'description': 'Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.'}, {'id': 'BG001', 'title': 'Norelgestrominum and Ethinylestradiol Contraceptive Patch', 'description': 'A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.'}, {'id': 'BG002', 'title': 'Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring', 'description': 'NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.6', 'spread': '5.44', 'groupId': 'BG000'}, {'value': '24.8', 'spread': '6.59', 'groupId': 'BG001'}, {'value': '23.1', 'spread': '3.64', 'groupId': 'BG002'}, {'value': '24.5', 'spread': '5.24', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', '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', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-02', 'studyFirstSubmitDate': '2010-01-05', 'resultsFirstSubmitDate': '2010-02-11', 'studyFirstSubmitQcDate': '2010-01-06', 'lastUpdatePostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-03-17', 'studyFirstPostDateStruct': {'date': '2010-01-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Concentration (Cmax) (Pharmacokinentic Parameter (PK)) for All Subjects in the Pharmacokinetically Evaluable (ASPE) Group', 'timeFrame': '21 days of active treatment and washout period thereafter', 'description': 'Cmax was measured using ethinylstradiol serum concentration at several time points during the 21 days of active treatment and the washout thereafter.'}, {'measure': 'Area Under the Curve (AUC) 0-21 Days (PK Parameter) Measured for the ASPE Group', 'timeFrame': '21 days', 'description': 'AUC 0-21 days was measured using ethinylestradiol serum concentration using a radio-immune assay at several time points during the 21 days of active treatment'}, {'measure': 'AUC 0-tlast (PK Parameter) for the ASPE Group.', 'timeFrame': '21 days of active treatment and washout period thereafter', 'description': 'AUC 0-tlast was measured using ethinylestradiol serum concentrations using a radio-immune assay at several time points during the 21 days of active treatment and the washout period thereafter.'}, {'measure': 'AUC 0-infinity (PK Parameter) for the ASPE Group.', 'timeFrame': '21 days of active treatment and the washout period thereafter', 'description': 'AUC 0-infinity was measured using ethinylestradiol serum concentration using a radio-immune assay at several time points during the 21 days of active treatment and the washout period thereafter. AUC 0-infinity was calculated as AUC 0-tlast extrapolated to infinity using the regression line from which t 1/2 was calculated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Contraception']}, 'referencesModule': {'references': [{'pmid': '16102549', 'type': 'RESULT', 'citation': 'van den Heuvel MW, van Bragt AJ, Alnabawy AK, Kaptein MC. Comparison of ethinylestradiol pharmacokinetics in three hormonal contraceptive formulations: the vaginal ring, the transdermal patch and an oral contraceptive. Contraception. 2005 Sep;72(3):168-74. doi: 10.1016/j.contraception.2005.03.005.'}]}, 'descriptionModule': {'briefSummary': 'An open-label, randomized, parallel group trial in healthy female subjects to compare the pharmacokinetics of ethinyl estradiol (EE) of NuvaRing®, a contraceptive patch (EVRA(TM)) and an oral contraceptive (Microgynon® 30).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is at least 18 but not older than 40 years of age on Day 1 of treatment.\n* Subject has uterus and ovaria in situ\n* Subject who does not use hormonal contraception and is willing to use adequate nonhormonal contraceptive measures during the timeframe between screening and start treatment.\n* Subject is able and willing to refrain from caffeine and/or xanthine containing food and/or beverages (e.g. coffee, tea, cola or chocolate) from 24 hours before the first administration of the trial medication until the last PK blood sample.\n* Subject is willing not to consume grapefruit containing products 14 days prior to the start of the first administration of the trial medication until the last PK blood sample.\n* Subject is willing to refrain from smoking from 7 days prior to first administration of the trial medication until the last pharmacokinetic blood sample.\n* Subject is willing to refrain from alcohol containing products from 24 hours prior to first administration of the trial medication until the last pharmacokinetic blood sample.\n\nExclusion Criteria:\n\n* Contraindications for use of NuvaRing, contraceptive patch and oral contraceptive:\n* Presence or history of venous thrombosis, with or without the involvement of pulmonary embolism.\n* Presence or history of arterial thrombosis (e.g. cerebrovascular accident, myocardial infarction) or prodromi of a thrombosis (e.g. angina pectoris or transient ischaemic attack).\n* Known predisposition for venous or arterial thrombosis, with or without hereditary involvement such as Activated Protein C (APC) resistance, antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant) and Factor V Leiden mutation.\n* Diabetes mellitus with vascular involvement\n* The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis (to be judged by the (sub-) investigator\n* Presence or history of severe hepatic disease as long as liver function values had not returned to normal or were judged to be clinically significant by the investigator.\n* Presence or history of liver tumours (benign or malignant).\n* Known or suspected malignant conditions of the genital organs or the breasts, if sex-steroid-influenced.\n* Undiagnosed vaginal bleeding.\n* Hypersensitivity to the active substances or to any of the excipients of NuvaRing, contraceptive patch and oral contraceptive.\n* Migraine with focal aura\n* Known or suspected pregnancy\n* Breastfeeding, or within 2 months after stopping breastfeeding on the day preceding the first administration of trial medication (Day -1).\n* Clinically significant abnormal laboratory, ECG (electrocardiogram) vital signs, physical and gynecological findings at screening.\n* A significant (history of) allergic or other serious disease, particularly gastrointestinal tract disease.\n* Smoking more than 5 cigarettes or 1 pipe or 1 cigar per day for a period of at least 3 months prior to screening.\n* Using any systemic medication (including over the counter (OTC) medication) during the 14 days prior to the day preceding the first administration of trial medication (Day -1), except for oral contraceptive used for synchronization and occasional Ibuprofen.\n* Used any drug or substance that is known to induce drug-metabolizing enzymes within two months prior to the start of synchronization.\n* Received a contraceptive by injection, an implant or hormonal intra-uterine device within 6 months of the day preceding the first administration of trial medication (Day -1), or a hormonal implant or hormonal intra-uterine device removed within 6 months of the day preceding the first administration of trial medication (Day -1).\n* Participated in a drug trial and was administered an investigational drug during the 90 days prior to start of synchronization.\n* Donated blood during the 90 days prior to the day preceding the first administration of trial medication (Day -1).\n* History (within the last 2 years) of excessive alcohol use, use of solvents or of drug abuse.\n* Positive drug test at screening and/or admission (Day -1), or a positive alcohol test at admission (Day -1).\n* Clinically significant abnormal cervical smear result (papaninecolaou (PAP) III or higher) at screening.\n* Acute or chronic hepatitis B/C or human immune deficiency virus (HIV) 1\\&2 infection.'}, 'identificationModule': {'nctId': 'NCT01044056', 'briefTitle': 'A Trial in Healthy Female Subjects to Compare the Pharmacokinetics of Ethinyl Estradiol of NuvaRing®, a Contraceptive Patch (EVRA(TM)) and an Oral Contraceptive (Microgynon® 30) (Study 34237 (P06650)) (COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'An Open-label, Randomized, Parallel Group Trial in Healthy Female Subjects to Compare the Pharmacokinetics of Ethinyl Estradiol of NuvaRing®, a Contraceptive Patch (EVRA(TM)) and an Oral Contraceptive (Microgynon® 30)', 'orgStudyIdInfo': {'id': 'P06650'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Levonorgestrel/ethinylestradiol oral contraceptive pill', 'description': 'Microgynon(R), 1 tablet every day for 21 days; each tablet contains 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE).', 'interventionNames': ['Drug: Levonorgestrel (LNG)/Ethinylestradiol (EE) oral contraceptive tablets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Norelgestrominum and ethinylestradiol contraceptive patch', 'description': 'Evra(TM), One patch applied on lower abdomen for 7 days for 3 consecutive weeks, 3 patches in total. Each patch contains 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.', 'interventionNames': ['Drug: norelgestrominum and ethinylestradiol patch oral contraceptive patch']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Etonogestrel and ethinylestradiol contraceptive vaginal ring', 'description': 'Nuvaring(R), Place the ring in the vagina for 21 days, remove for one week. Repeat with new Ring. Dose: per ring 11.7 mg ENG and 2.7 mg EE releasing a daily average amount of 0.120 mg ENG and 0.015 mg EE.', 'interventionNames': ['Drug: Nuvaring ™ (etonorgestrel/ethinylestradiol)']}], 'interventions': [{'name': 'Levonorgestrel (LNG)/Ethinylestradiol (EE) oral contraceptive tablets', 'type': 'DRUG', 'otherNames': ['Microgynon', 'Batch Number: 374A 01K05'], 'description': 'LNG/EE oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.', 'armGroupLabels': ['Levonorgestrel/ethinylestradiol oral contraceptive pill']}, {'name': 'norelgestrominum and ethinylestradiol patch oral contraceptive patch', 'type': 'DRUG', 'otherNames': ['EVRA ™', 'Batch number : 0311264'], 'description': 'A contraceptive patch (EVRA ™), one patch for 7 days for three consecutive weeks, 3 patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.', 'armGroupLabels': ['Norelgestrominum and ethinylestradiol contraceptive patch']}, {'name': 'Nuvaring ™ (etonorgestrel/ethinylestradiol)', 'type': 'DRUG', 'description': 'NuvaRing ™ , one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.', 'armGroupLabels': ['Etonogestrel and ethinylestradiol contraceptive vaginal ring']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}