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Influence of Pharmacogenetic Factors, Paroxetine and Clarithromycin on Pharmacokinetics of Clomiphene

NCT01289756 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-02-24

No results posted yet for this study

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.

Conditions

  • Anovulation
  • Disorder Due Cytochrome P450 CYP2D6 Variant
  • Cytochrome P450 CYP3A Enzyme Deficiency

Interventions

DRUG

Clomiphene

clomiphene once 100 mg oral

DRUG

clomiphene and paroxetine

clomiphene 100mg and paroxetine 3x40mg

DRUG

clomiphene and clarithromycin

clomiphene 100mg and clarithromycin 9x500mg

Sponsors & Collaborators

  • Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

    lead OTHER

Principal Investigators

  • Matthias Schwab, Prof. · Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01289756 on ClinicalTrials.gov