Ignite Creation Date:
2025-12-25 @ 1:09 AM
Ignite Modification Date:
2025-12-27 @ 2:05 AM
Study NCT ID:
NCT04964193
Status:
COMPLETED
Last Update Posted:
2022-01-31
First Post:
2021-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bioequivalence Study of Cyproterone Acetate and Ethinyl Estradiol in Healthy Female Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017373', 'term': 'Cyproterone Acetate'}, {'id': 'D004997', 'term': 'Ethinyl Estradiol'}], 'ancestors': [{'id': 'D003534', 'term': 'Cyproterone'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013258', 'term': 'Steroids, Chlorinated'}, {'id': 'D009651', 'term': 'Norpregnatrienes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D042782', 'term': 'Estrogenic Steroids, Alkylated'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nabila.sutanto@pharmametriclabs.com', 'phone': '+62 21 4265310', 'title': 'Pharma Metric Labs', 'organization': 'Pharma Metric Labs, Indonesia'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing', 'description': '\\[Not Specified\\]', 'eventGroups': [{'id': 'EG000', 'title': 'Elzsa Film-coated Tablet', 'description': 'New (test) Elzsa film-coated tablet (2 mg cyproterone acetate + 0.035 mg ethinylestradiol) as a single oral dose.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 6, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Diane-35 Sugar-coated Tablet', 'description': 'Marketed (reference) Diane-35 Sugar-coated tablet ( 2 mg cyproterone acetate + 0.035 mg ethinylestradiol) as a single oral dose.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 9, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast tenderness or Breast discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Frequently Urination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flu like symptoms (Runny rose nose, headache)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetics Parameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Elzsa Film-coated Tablet', 'description': 'Participants received Elzsa film-coated tablet (2 mg cyproterone acetate + 0.035 mg ethinylestradiol) with 240 mL of water\n\nElzsa film-coated tablet: Administered with 240 mL of water'}, {'id': 'OG001', 'title': 'Diane-35 Sugar-coated Tablet', 'description': 'Participants received Diane-35 Sugar-coated tablet ( 2 mg cyproterone acetate + 0.035 mg ethinylestradiol) with 240 mL of water\n\nDiane-35 Sugar-coated tablet: Administered with 240 mL of water'}], 'classes': [{'title': 'Cmax of Cyproterone Acetate', 'categories': [{'measurements': [{'value': '17.39', 'spread': '13.77', 'groupId': 'OG000'}, {'value': '16.20', 'spread': '13.81', 'groupId': 'OG001'}]}]}, {'title': 'Cmax of Ethinyl Estradiol', 'categories': [{'measurements': [{'value': '103.69', 'spread': '47.42', 'groupId': 'OG000'}, {'value': '93.61', 'spread': '47.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'before dosing (0 h) and at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing', 'description': 'Maximum plasma concentration (Cmax)', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics Parameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Elzsa Film-coated Tablet', 'description': 'Participants received Elzsa film-coated tablet (2 mg cyproterone acetate + 0.035 mg ethinylestradiol) with 240 mL of water\n\nElzsa film-coated tablet: Administered with 240 mL of water'}, {'id': 'OG001', 'title': 'Diane-35 Sugar-coated Tablet', 'description': 'Participants received Diane-35 Sugar-coated tablet ( 2 mg cyproterone acetate + 0.035 mg ethinylestradiol) with 240 mL of water\n\nDiane-35 Sugar-coated tablet: Administered with 240 mL of water'}], 'classes': [{'title': 'AUC0-t of Cyproterone Acetate', 'categories': [{'measurements': [{'value': '132.56', 'spread': '73.19', 'groupId': 'OG000'}, {'value': '127.54', 'spread': '89.41', 'groupId': 'OG001'}]}]}, {'title': 'AUC0-t of Ethinyl Estradiol', 'categories': [{'measurements': [{'value': '870.45', 'spread': '383.56', 'groupId': 'OG000'}, {'value': '842.56', 'spread': '398.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'before dosing (0 h) and at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing', 'description': 'Area Under Curve from 0 to 72 hours (AUCt)', 'unitOfMeasure': 'pg*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test Drug First, Then Reference Drug', 'description': 'New (test) Elzsa film-coated tablet (2 mg cyproterone acetate + 0.035 mg ethinylestradiol) as a single oral dose in the first intervention period, and marketed (reference) Diane®-35 sugar-coated tablet (2 mg cyproterone acetate + 0.035 mg ethinylestradiol) as a single oral dose in the second intervention period (after washout period).'}, {'id': 'FG001', 'title': 'Diane-35 Sugar-coated Tablet', 'description': 'Marketed (reference) Diane-35 Sugar-coated tablet (2 mg cyproterone acetate + 0.035 mg ethinylestradiol) as a single oral dose in the first intervention period, and new (test) Elzsa film-coated tablet (2 mg cyproterone acetate + 0.035 mg ethinylestradiol) as a single oral dose in the second intervention period (after washout period).'}], 'periods': [{'title': '1st Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout = Three Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': '2nd Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Total Number of Participants', 'description': 'All participants received 2 mg cyproterone acetate + 0.035 mg ethinylestradiol tablet (new and marketed)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-12', 'size': 951477, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-01-28T05:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized, single blind, two-period, single dose, crossover study with three weeks washout period in 24 healthy female subjects under fasting condition.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-28', 'studyFirstSubmitDate': '2021-04-14', 'resultsFirstSubmitDate': '2021-07-19', 'studyFirstSubmitQcDate': '2021-07-05', 'lastUpdatePostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-28', 'studyFirstPostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics Parameter', 'timeFrame': 'before dosing (0 h) and at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing', 'description': 'Maximum plasma concentration (Cmax)'}, {'measure': 'Pharmacokinetics Parameter', 'timeFrame': 'before dosing (0 h) and at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing', 'description': 'Area Under Curve from 0 to 72 hours (AUCt)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cyproterone acetate', 'ethinyl estradiol', 'bioequivalence', 'cross-over design study', 'pharmacokinetics', 'Indonesian healthy female'], 'conditions': ['Drug Use']}, 'referencesModule': {'references': [{'pmid': '17426085', 'type': 'RESULT', 'citation': 'Luque-Ramirez M, Alvarez-Blasco F, Botella-Carretero JI, Martinez-Bermejo E, Lasuncion MA, Escobar-Morreale HF. Comparison of ethinyl-estradiol plus cyproterone acetate versus metformin effects on classic metabolic cardiovascular risk factors in women with the polycystic ovary syndrome. J Clin Endocrinol Metab. 2007 Jul;92(7):2453-61. doi: 10.1210/jc.2007-0282. Epub 2007 Apr 10.'}, {'pmid': '22795636', 'type': 'RESULT', 'citation': 'Bhattacharya SM, Jha A. Comparative study of the therapeutic effects of oral contraceptive pills containing desogestrel, cyproterone acetate, and drospirenone in patients with polycystic ovary syndrome. Fertil Steril. 2012 Oct;98(4):1053-9. doi: 10.1016/j.fertnstert.2012.06.035. Epub 2012 Jul 13.'}, {'pmid': '14667981', 'type': 'RESULT', 'citation': 'Elger W, Beier S, Pollow K, Garfield R, Shi SQ, Hillisch A. Conception and pharmacodynamic profile of drospirenone. Steroids. 2003 Nov;68(10-13):891-905. doi: 10.1016/j.steroids.2003.08.008.'}, {'pmid': '28447864', 'type': 'RESULT', 'citation': 'Bitzer J, Romer T, Lopes da Silva Filho A. The use of cyproterone acetate/ethinyl estradiol in hyperandrogenic skin symptoms - a review. Eur J Contracept Reprod Health Care. 2017 Jun;22(3):172-182. doi: 10.1080/13625187.2017.1317339. Epub 2017 Apr 27.'}, {'pmid': '949892', 'type': 'RESULT', 'citation': 'Speck U, Wendt H, Schulze PE, Jentsch D. Bio-availability and pharmacokinetics of cyproterone acetate-14C and ethinyloestradiol-3H after oral administration as a coated tablet (SH B 209 AB). Contraception. 1976 Aug;14(2):151-63. doi: 10.1016/0010-7824(76)90083-4.'}, {'pmid': '8131397', 'type': 'RESULT', 'citation': 'Kuhnz W, Staks T, Jutting G. Pharmacokinetics of cyproterone acetate and ethinylestradiol in 15 women who received a combination oral contraceptive during three treatment cycles. Contraception. 1993 Dec;48(6):557-75. doi: 10.1016/0010-7824(93)90118-q.'}, {'pmid': '26253465', 'type': 'RESULT', 'citation': 'Sedgwick P. Bias in randomised controlled trials: comparison of crossover group and parallel group designs. BMJ. 2015 Aug 7;351:h4283. doi: 10.1136/bmj.h4283. No abstract available.'}, {'pmid': '15580599', 'type': 'RESULT', 'citation': 'Garcia R, Benet M, Arnau C, Cobo E. Efficiency of the cross-over design: an empirical estimation. Stat Med. 2004 Dec 30;23(24):3773-80. doi: 10.1002/sim.2072.'}, {'pmid': '25134118', 'type': 'RESULT', 'citation': 'Sedgwick P. What is a crossover trial? BMJ. 2014 May 9;348:g3191. doi: 10.1136/bmj.g3191. No abstract available.'}, {'pmid': '25954990', 'type': 'RESULT', 'citation': 'Sedgwick P. Randomised controlled trials: "within subject" versus "between subject" designs. BMJ. 2014 Oct 24;349:g6435. doi: 10.1136/bmj.g6435. No abstract available.'}], 'seeAlsoLinks': [{'url': 'http://www.ema.europa.eu/en/documents/referral/cyproterone/ethinylestradiol-containing-medicines-article-107i-procedure-prac-assessment-report_en.pdf', 'label': '(accessed on Sep 18, 2020)'}]}, 'descriptionModule': {'briefSummary': 'The study was conducted to investigate whether 2 mg cyproterone acetate (CPA) and 0.035 mg ethinyl estradiol (EE) film-coated tablet (Elzsa®) manufactured by PT. Sydna Farma was bioequivalent to its reference product, Diane®-35 sugar-coated tablet manufactured by Bayer Weimar GmbH, Germany, imported by PT. Bayer Indonesia, Depok, Indonesia.', 'detailedDescription': 'Twenty four healty female subjects were given a single dose of Elzsa® FCT or or Diane®-35 with 240 mL of water. Then the blood samples for CPA and EE were drawn and analyzed using LCMS/MS. All subjects sample plasma were analyzed for pharmacokinetic evaluation'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '54 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria\n\nThe inclusion criteria are healthy female subjects who/with:\n\n* have read the subject information and signed informed consent documents\n* age 18 - 55 years\n* body mass index between 18-25 kg/m2\n* have a normal electrocardiogram\n* blood pressure within normal range (90-120 mmHg for systolic blood pressure and 60-80 mmHg for diastolic blood pressure)\n* heart rate within normal range (60-100 bpm)\n* with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening\n* pass hormone screening related to cyproterone acetate and ethinyl estradiol\n\nExclusion criteria\n\nAny of the following criteria will exclude the subject from the study:\n\n* those who are pregnant and/or nursing woman.\n* those with history of hypersensitivity to cyproterone acetate and ethinyl estradiol or other oral contraception or other ingredients in the drugs or a history of serious allergic reaction to any drug, significant allergic disease, allergic reaction, or active allergic.\n* those with a history or presence medical condition which might significantly influence the pharmacokinetic of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease.\n* those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities, thrombophlebitis, and thromboembolic disorder.\n* those who are using any medication (prescription or non-prescription drug, food supplement, herbal medicine, oral contraception, anti-platelet drug), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day.\n* those who have participated in any clinical study within 3 months prior to the study (\\< 90 days).\n* those who have donated or lost 300 ml (or more) of blood within 3 months prior to the study.\n* those who smoke.\n* those who are positive to HIV, HBsAg, and HCV tests (to be kept confidential).\n* those with a history of drug or alcohol abuse within 12 months prior to screening for this study.\n* those who are unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access.'}, 'identificationModule': {'nctId': 'NCT04964193', 'briefTitle': 'Bioequivalence Study of Cyproterone Acetate and Ethinyl Estradiol in Healthy Female Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'PT Sydna Farma'}, 'officialTitle': 'Bioequivalence Study of 2 mg Cyproterone Acetate and 0.035 mg Ethinyl Estradiol in Indonesian Healthy Females', 'orgStudyIdInfo': {'id': '440/STD/PML/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Elzsa film-coated tablet', 'description': 'Participants received Elzsa film-coated tablet (2 mg cyproterone acetate + 0.035 mg ethinylestradiol) with 240 mL of water', 'interventionNames': ['Drug: Elzsa film-coated tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diane-35 Sugar-coated tablet', 'description': 'Participants received Diane-35 Sugar-coated tablet ( 2 mg cyproterone acetate + 0.035 mg ethinylestradiol) with 240 mL of water', 'interventionNames': ['Drug: Diane-35 Sugar-coated tablet']}], 'interventions': [{'name': 'Elzsa film-coated tablet', 'type': 'DRUG', 'otherNames': ['2 mg cyproterone acetate + 0.035 mg ethinylestradiol'], 'description': 'Administered with 240 mL of water', 'armGroupLabels': ['Elzsa film-coated tablet']}, {'name': 'Diane-35 Sugar-coated tablet', 'type': 'DRUG', 'otherNames': ['2 mg cyproterone acetate + 0.035 mg ethinylestradiol'], 'description': 'Administered with 240 mL of water', 'armGroupLabels': ['Diane-35 Sugar-coated tablet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10520', 'city': 'Multiple Locations', 'state': 'Jakarta Special Capital Region', 'country': 'Indonesia', 'facility': 'PT Pharma Metric Labs'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PT Sydna Farma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'PT Pharma Metric Labs', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}