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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-014531-20 | EudraCT Number |
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Aim of the study is the clinical validation of the metabolism and the pharmakokinetic of Clomifen in correlation to CYP2D6 and inhibition of CYP3A4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CYP2D6 EM | Experimental | clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin |
|
| CYP2D6 IM | Experimental | clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin |
|
| CYP2D6 PM | Experimental | clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin |
|
| CYP2D6 UM | Experimental | clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clomiphene | Drug | clomiphene once 100 mg oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC)of clomiphene | AUC of clomiphene and metabolites | 1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after durg application |
| Peak Plasma Concentration (Cmax)of Clomiphene | Cmax of Clomiphene and metabolites | 1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after drug application |
| Measure | Description | Time Frame |
|---|---|---|
| Clearance of Clomiphene | Clearance of Clomiphene and metabolites | 4, 8, 12 and 24 hours after drug application |
| Metabolomic | Metabolomic |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Schwab, Prof. | Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology and University of Tuebingen | Stuttgart | Baden-Wurttemberg | 70376 | Germany |
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| clomiphene and paroxetine | Drug | clomiphene 100mg and paroxetine 3x40mg |
|
| clomiphene and clarithromycin | Drug | clomiphene 100mg and clarithromycin 9x500mg |
|
| 4, 8, 12 and 24 hours after drug application |
| Tmax of clomiphene | Tmax of clomiphene and metabolites | 4, 8, 12, 24 hours after drug application |
| Pharmacogenomics | Pharmacogenomics | once |
| ID | Term |
|---|---|
| D000858 | Anovulation |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D002996 | Clomiphene |
| D017374 | Paroxetine |
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
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