Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT01289756
Status:
COMPLETED
Last Update Posted:
2015-02-24
First Post:
2011-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Pharmacogenetic Factors, Paroxetine and Clarithromycin on Pharmacokinetics of Clomiphene
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000858', 'term': 'Anovulation'}], 'ancestors': [{'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002996', 'term': 'Clomiphene'}, {'id': 'D017374', 'term': 'Paroxetine'}, {'id': 'D017291', 'term': 'Clarithromycin'}], 'ancestors': [{'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-23', 'studyFirstSubmitDate': '2011-02-02', 'studyFirstSubmitQcDate': '2011-02-03', 'lastUpdatePostDateStruct': {'date': '2015-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma concentration versus time curve (AUC)of clomiphene', 'timeFrame': '1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after durg application', 'description': 'AUC of clomiphene and metabolites'}, {'measure': 'Peak Plasma Concentration (Cmax)of Clomiphene', 'timeFrame': '1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after drug application', 'description': 'Cmax of Clomiphene and metabolites'}], 'secondaryOutcomes': [{'measure': 'Clearance of Clomiphene', 'timeFrame': '4, 8, 12 and 24 hours after drug application', 'description': 'Clearance of Clomiphene and metabolites'}, {'measure': 'Metabolomic', 'timeFrame': '4, 8, 12 and 24 hours after drug application', 'description': 'Metabolomic'}, {'measure': 'Tmax of clomiphene', 'timeFrame': '4, 8, 12, 24 hours after drug application', 'description': 'Tmax of clomiphene and metabolites'}, {'measure': 'Pharmacogenomics', 'timeFrame': 'once', 'description': 'Pharmacogenomics'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pharmacokinetic', 'clomiphene', 'CYP2D6 polymorphisms', 'inhibition of CYP2D6 and CYP3A4'], 'conditions': ['Anovulation', 'Disorder Due Cytochrome P450 CYP2D6 Variant', 'Cytochrome P450 CYP3A Enzyme Deficiency']}, 'descriptionModule': {'briefSummary': 'Aim of the study is the clinical validation of the metabolism and the pharmakokinetic of Clomifen in correlation to CYP2D6 and inhibition of CYP3A4.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Female caucasians\n* Age 18 - 45 years old\n* BMI 18.5 - 26 kg/m2\n\nExclusion Criteria:\n\n* Persons with known sensitivity of Clomifen and/or Paroxetine and/or Clarithromycin\n* Pregnancy/lactation period\n* Meno-/postmenopausal\n* Smokers'}, 'identificationModule': {'nctId': 'NCT01289756', 'briefTitle': 'Influence of Pharmacogenetic Factors, Paroxetine and Clarithromycin on Pharmacokinetics of Clomiphene', 'organization': {'class': 'OTHER', 'fullName': 'Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)'}, 'officialTitle': 'Influence of Pharmacogenetic Factors, Paroxetine and Clarithromycin on Pharmacokinetics of Clomiphene', 'orgStudyIdInfo': {'id': 'IKP237'}, 'secondaryIdInfos': [{'id': '2009-014531-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CYP2D6 EM', 'description': 'clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin', 'interventionNames': ['Drug: Clomiphene', 'Drug: clomiphene and paroxetine', 'Drug: clomiphene and clarithromycin']}, {'type': 'EXPERIMENTAL', 'label': 'CYP2D6 IM', 'description': 'clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin', 'interventionNames': ['Drug: Clomiphene', 'Drug: clomiphene and paroxetine', 'Drug: clomiphene and clarithromycin']}, {'type': 'EXPERIMENTAL', 'label': 'CYP2D6 PM', 'description': 'clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin', 'interventionNames': ['Drug: Clomiphene', 'Drug: clomiphene and paroxetine', 'Drug: clomiphene and clarithromycin']}, {'type': 'EXPERIMENTAL', 'label': 'CYP2D6 UM', 'description': 'clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin', 'interventionNames': ['Drug: Clomiphene', 'Drug: clomiphene and paroxetine', 'Drug: clomiphene and clarithromycin']}], 'interventions': [{'name': 'Clomiphene', 'type': 'DRUG', 'description': 'clomiphene once 100 mg oral', 'armGroupLabels': ['CYP2D6 EM', 'CYP2D6 IM', 'CYP2D6 PM', 'CYP2D6 UM']}, {'name': 'clomiphene and paroxetine', 'type': 'DRUG', 'description': 'clomiphene 100mg and paroxetine 3x40mg', 'armGroupLabels': ['CYP2D6 EM', 'CYP2D6 IM', 'CYP2D6 PM', 'CYP2D6 UM']}, {'name': 'clomiphene and clarithromycin', 'type': 'DRUG', 'description': 'clomiphene 100mg and clarithromycin 9x500mg', 'armGroupLabels': ['CYP2D6 EM', 'CYP2D6 IM', 'CYP2D6 PM', 'CYP2D6 UM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70376', 'city': 'Stuttgart', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology and University of Tuebingen', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}], 'overallOfficials': [{'name': 'Matthias Schwab, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. M.D.', 'investigatorFullName': 'Matthias Schwab', 'investigatorAffiliation': 'Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)'}}}}