Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-28 @ 2:16 PM
Study NCT ID:
NCT01623466
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2012-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate Pharmacokinetics Profile, Wearability, and Safety of 2 Progestin-Only Patches
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'D016912', 'term': 'Levonorgestrel'}, {'id': 'D057968', 'term': 'Transdermal Patch'}], 'ancestors': [{'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': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lflood@agiletherapeutics.com', 'phone': '609-683-1880', 'title': 'Lisa Flood', 'organization': 'Agile Therapeutics'}, 'certainAgreement': {'otherDetails': 'All publications must be reviewed and approved by sponsor', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'AG890-6.5', 'description': 'Evaluate levonorgestrel delivery in AG890-6.5\n\nlevonorgestrel: transdermal contraceptive delivery system', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 11, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'AG890-12.5', 'description': 'Evaluate levonorgestrel delivery in AG890-12.5\n\nlevonorgestrel: transdermal contraceptive delivery system', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 9, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Gastrointestinal Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Immune system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolism and nutrition disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervous system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Reproductive system ad breast disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin and subcutaneous tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Levonorgestrel Pharmacokinetic Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AG890-6.5', 'description': 'Evaluate levonorgestrel delivery in AG890-6.5\n\nlevonorgestrel: transdermal contraceptive delivery system'}, {'id': 'OG001', 'title': 'AG890-12.5', 'description': 'Evaluate levonorgestrel delivery in AG890-12.5\n\nlevonorgestrel: transdermal contraceptive delivery system'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '83.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'The percentage of subjects with a minimal LNG level below pre-specified threshold of 175 pg/mL during the study.', 'unitOfMeasure': '% of subjects below 175 pg/mL', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary PK population'}, {'type': 'PRIMARY', 'title': 'Evaluation of Patch Adhesion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AG890-6.5', 'description': 'Evaluate levonorgestrel delivery in AG890-6.5\n\nlevonorgestrel: transdermal contraceptive delivery system'}, {'id': 'OG001', 'title': 'AG890-12.5', 'description': 'Evaluate levonorgestrel delivery in AG890-12.5\n\nlevonorgestrel: transdermal contraceptive delivery system'}], 'classes': [{'categories': [{'measurements': [{'value': '0.41', 'spread': '1.004', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '1.517', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Evaluation of worst patch adhesion score for each subject using a 5-point adhesion scale:\n\n0: ≥90% adhered (no lift)\n\n1. ≥75% adhered but \\<90% (some edges showing lift)\n2. ≥50% adhered but \\<75% (half of system lifts off)\n3. \\<50% (\\< half of system lifts off, but undetached)\n4. patch completely detached', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'PRIMARY', 'title': 'Evaluation of Irritation at Patch Application Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AG890-6.5', 'description': 'Evaluate levonorgestrel delivery in AG890-6.5\n\nlevonorgestrel: transdermal contraceptive delivery system'}, {'id': 'OG001', 'title': 'AG890-12.5', 'description': 'Evaluate levonorgestrel delivery in AG890-12.5\n\nlevonorgestrel: transdermal contraceptive delivery system'}], 'classes': [{'categories': [{'measurements': [{'value': '0.11', 'spread': '0.471', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.236', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Self-reported worst skin irritation score at patch application site for each subject using a 4-point irritation scale:\n\n0: None\n\n1. Mild\n2. Moderate\n3. Severe', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'PRIMARY', 'title': 'Evaluation of Itching at Patch Application Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AG890-6.5', 'description': 'Evaluate levonorgestrel delivery in AG890-6.5\n\nlevonorgestrel: transdermal contraceptive delivery system'}, {'id': 'OG001', 'title': 'AG890-12.5', 'description': 'Evaluate levonorgestrel delivery in AG890-12.5\n\nlevonorgestrel: transdermal contraceptive delivery system'}], 'classes': [{'categories': [{'measurements': [{'value': '0.33', 'spread': '0.594', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '0.502', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Self-reported worst skin itching at patch application site by subject using a 4-point scale:\n\n0\\. None\n\n1. Mild\n2. Moderate\n3. Severe', 'unitOfMeasure': 'Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'PRIMARY', 'title': 'Cycle Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AG890-6.5', 'description': 'Evaluate levonorgestrel delivery in AG890-6.5\n\nlevonorgestrel: transdermal contraceptive delivery system'}, {'id': 'OG001', 'title': 'AG890-12.5', 'description': 'Evaluate levonorgestrel delivery in AG890-12.5\n\nlevonorgestrel: transdermal contraceptive delivery system'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '4.81', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '4.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Measurement of unscheduled bleeding/spotting days.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Completed subjects'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AG890-6.5', 'description': 'Evaluate levonorgestrel delivery in AG890-6.5\n\nlevonorgestrel: transdermal contraceptive delivery system'}, {'id': 'FG001', 'title': 'AG890-12.5', 'description': 'Evaluate levonorgestrel delivery in AG890-12.5\n\nlevonorgestrel: transdermal contraceptive delivery system'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AG890-6.5', 'description': 'Evaluate levonorgestrel delivery in AG890-6.5\n\nlevonorgestrel: transdermal contraceptive delivery system'}, {'id': 'BG001', 'title': 'AG890-12.5', 'description': 'Evaluate levonorgestrel delivery in AG890-12.5\n\nlevonorgestrel: transdermal contraceptive delivery system'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.83', 'spread': '8.473', 'groupId': 'BG000'}, {'value': '34.94', 'spread': '6.673', 'groupId': 'BG001'}, {'value': '32.39', 'spread': '7.951', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-21', 'studyFirstSubmitDate': '2012-06-18', 'resultsFirstSubmitDate': '2017-07-26', 'studyFirstSubmitQcDate': '2012-06-19', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-26', 'studyFirstPostDateStruct': {'date': '2012-06-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Levonorgestrel Pharmacokinetic Profile', 'timeFrame': '8 weeks', 'description': 'The percentage of subjects with a minimal LNG level below pre-specified threshold of 175 pg/mL during the study.'}, {'measure': 'Evaluation of Patch Adhesion', 'timeFrame': '8 weeks', 'description': 'Evaluation of worst patch adhesion score for each subject using a 5-point adhesion scale:\n\n0: ≥90% adhered (no lift)\n\n1. ≥75% adhered but \\<90% (some edges showing lift)\n2. ≥50% adhered but \\<75% (half of system lifts off)\n3. \\<50% (\\< half of system lifts off, but undetached)\n4. patch completely detached'}, {'measure': 'Evaluation of Irritation at Patch Application Site', 'timeFrame': '8 weeks', 'description': 'Self-reported worst skin irritation score at patch application site for each subject using a 4-point irritation scale:\n\n0: None\n\n1. Mild\n2. Moderate\n3. Severe'}, {'measure': 'Evaluation of Itching at Patch Application Site', 'timeFrame': '8 weeks', 'description': 'Self-reported worst skin itching at patch application site by subject using a 4-point scale:\n\n0\\. None\n\n1. Mild\n2. Moderate\n3. Severe'}, {'measure': 'Cycle Control', 'timeFrame': '8 weeks', 'description': 'Measurement of unscheduled bleeding/spotting days.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PK and Safety'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Pharmacokinetics, safety and wearability in two size patches of AG890 over eight weeks will be evaluated.', 'detailedDescription': 'To evaluate pharmacokinetic (PK) profile, patch wearability (adhesion and skin irritation), and safety of AG890-6.5 and AG890-12.5 TCDS.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Body mass index (BMI) greater than or equal to 18.\n* Willing to use a non-hormonal method of contraception if of childbearing potential, or have already undergone previous bilateral tubal ligation or hysterectomy\n* Willing to refrain from excessive use of alcohol from 48 hours prior to patch application through completion of the study.\n\nExclusion Criteria:\n\n* Known or suspected pregnancy\n* Lactating women\n* Status post-partum or post-abortion within a period of 2 months prior to the start of study medication\n* A cervical cytology smear of Papanicolaou (Pap) class III or greater or a Bethesda System report of low grade squamous intraepithelial lesions (SIL) or greater\n* Smoking\n* Hypertension (blood pressure \\>140 mm Hg systolic and/or \\>90 mm Hg diastolic)\n* Valvular heart disease with complications\n* ECG (in women with BMI ≥35 kg/m2) with clinically significant findings\n* Diabetes Mellitus\n* History of headaches with focal neurological symptoms\n* Uncontrolled thyroid disorder\n* Sickle cell anemia\n* Current or history of clinically significant depression in the last year\n* Known disturbance of lipid metabolism\n* Acute or chronic hepatocellular disease with abnormal liver function\n* Hepatic adenoma or carcinoma\n* Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use\n* Plans for major surgery\n* History of or existing venous and arterial thrombotic and thromboembolic disorder, vascular disease, cerebral vascular, or coronary artery disease\n* Undiagnosed abnormal genital bleeding\n* Known or suspected breast carcinoma, endometrial carcinoma, or estrogen-dependent neoplasia\n* History or presence of dermal hypersensitivity in response to topical applications (bandages, surgical tape, etc.)\n* Use of an injectable hormonal contraceptive within the past 10 months prior to the screening visit\n* Use of a contraceptive implant or hormone-medicated intrauterine device (IUD) within 1 month prior to the screening visit\n* Use of oral contraceptives or other sex steroid hormones within 2 months prior to the screening visit\n* Chronic use of any medication that might interfere with the efficacy of hormone contraceptives (including barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's Wort, topiramate, and HIV protease inhibitors), OR use of these medications within the past 3 months prior to screening visit\n* A recent history (within prior 2 years ) of drug or alcohol abuse"}, 'identificationModule': {'nctId': 'NCT01623466', 'acronym': 'ATI-CL21', 'briefTitle': 'Study to Evaluate Pharmacokinetics Profile, Wearability, and Safety of 2 Progestin-Only Patches', 'organization': {'class': 'INDUSTRY', 'fullName': 'Agile Therapeutics'}, 'officialTitle': 'A Randomized, Open-Label, Parallel Group Study To Evaluate Pharmacokinetic Profile, Wearability And Safety of Two Progestin-Only Patches Containing Different Doses Of Levonorgestrel (LNG)', 'orgStudyIdInfo': {'id': 'ATI-CL21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AG890-6.5', 'description': 'Evaluate levonorgestrel delivery in AG890-6.5', 'interventionNames': ['Drug: levonorgestrel']}, {'type': 'EXPERIMENTAL', 'label': 'AG890-12.5', 'description': 'Evaluate levonorgestrel delivery in AG890-12.5', 'interventionNames': ['Drug: levonorgestrel']}], 'interventions': [{'name': 'levonorgestrel', 'type': 'DRUG', 'otherNames': ['patch, transdermal contraceptive delivery system'], 'description': 'transdermal contraceptive delivery system', 'armGroupLabels': ['AG890-12.5', 'AG890-6.5']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Elizabeth Garner, MD, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Agile Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Agile Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}