Influence of Pharmacogenetic Factors, Paroxetine and Clarithromycin on Pharmacokinetics of Clomiphene
Information source: Robert Bosch Gesellschaft für Medizinische Forschung mbH
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anovulation; Disorder Due Cytochrome P450 CYP2D6 Variant; Cytochrome P450 CYP3A Enzyme Deficiency
Intervention: Clomiphene (Drug); clomiphene and paroxetine (Drug); clomiphene and clarithromycin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Robert Bosch Gesellschaft für Medizinische Forschung mbH Official(s) and/or principal investigator(s): Matthias Schwab, Prof., Principal Investigator, Affiliation: Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology
Summary
Aim of the study is the clinical validation of the metabolism and the pharmakokinetic of
Clomifen in correlation to CYP2D6 and inhibition of CYP3A4.
Clinical Details
Official title: Influence of Pharmacogenetic Factors, Paroxetine and Clarithromycin on Pharmacokinetics of Clomiphene
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Area under the plasma concentration versus time curve (AUC)of clomiphenePeak Plasma Concentration (Cmax)of Clomiphene
Secondary outcome: Clearance of ClomipheneMetabolomic Tmax of clomiphene Pharmacogenomics
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Healthy
- Female caucasians
- Age 18 - 45 years old
- BMI 18. 5 - 26 kg/m2
Exclusion Criteria:
- Persons with known sensitivity of Clomifen and/or Paroxetine and/or Clarithromycin
- Pregnancy/lactation period
- Meno-/postmenopausal
- Smokers
Locations and Contacts
Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology and University of Tuebingen, Stuttgart, BW 70376, Germany
Additional Information
Starting date: December 2009
Last updated: February 23, 2015
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