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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 clomiphene

Peak Plasma Concentration (Cmax)of Clomiphene

Secondary outcome:

Clearance of Clomiphene

Metabolomic

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

Page last updated: August 23, 2015

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