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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Matthias Schwab, Robert Bosch Gesellschaft für Medizinische Forschung mbH
ClinicalTrials.gov Identifier:
NCT01289756
First received: February 2, 2011
Last updated: February 23, 2015
Last verified: February 2015
February 2, 2011
February 23, 2015
December 2009
November 2014   (Final data collection date for primary outcome measure)
  • Area under the plasma concentration versus time curve (AUC)of clomiphene [ Time Frame: 1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after durg application ]
    AUC of clomiphene and metabolites
  • Peak Plasma Concentration (Cmax)of Clomiphene [ Time Frame: 1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after drug application ]
    Cmax of Clomiphene and metabolites
Same as current
Complete list of historical versions of study NCT01289756 on ClinicalTrials.gov Archive Site
  • Clearance of Clomiphene [ Time Frame: 4, 8, 12 and 24 hours after drug application ]
    Clearance of Clomiphene and metabolites
  • Metabolomic [ Time Frame: 4, 8, 12 and 24 hours after drug application ]
    Metabolomic
  • Tmax of clomiphene [ Time Frame: 4, 8, 12, 24 hours after drug application ]
    Tmax of clomiphene and metabolites
  • Pharmacogenomics [ Time Frame: once ]
    Pharmacogenomics
Same as current
Not Provided
Not Provided
 
Influence of Pharmacogenetic Factors, Paroxetine and Clarithromycin on Pharmacokinetics of Clomiphene
Influence of Pharmacogenetic Factors, Paroxetine and Clarithromycin on Pharmacokinetics of Clomiphene
Aim of the study is the clinical validation of the metabolism and the pharmakokinetic of Clomifen in correlation to CYP2D6 and inhibition of CYP3A4.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Anovulation
  • Disorder Due Cytochrome P450 CYP2D6 Variant
  • Cytochrome P450 CYP3A Enzyme Deficiency
  • 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
  • Experimental: CYP2D6 EM
    clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
    Interventions:
    • Drug: Clomiphene
    • Drug: clomiphene and paroxetine
    • Drug: clomiphene and clarithromycin
  • Experimental: CYP2D6 IM
    clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
    Interventions:
    • Drug: Clomiphene
    • Drug: clomiphene and paroxetine
    • Drug: clomiphene and clarithromycin
  • Experimental: CYP2D6 PM
    clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
    Interventions:
    • Drug: Clomiphene
    • Drug: clomiphene and paroxetine
    • Drug: clomiphene and clarithromycin
  • Experimental: CYP2D6 UM
    clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
    Interventions:
    • Drug: Clomiphene
    • Drug: clomiphene and paroxetine
    • Drug: clomiphene and clarithromycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2014
November 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01289756
IKP237
2009-014531-20 ( EudraCT Number )
No
Not Provided
Not Provided
Matthias Schwab, Robert Bosch Gesellschaft für Medizinische Forschung mbH
Robert Bosch Gesellschaft für Medizinische Forschung mbH
Not Provided
Principal Investigator: Matthias Schwab, Prof. Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology
Robert Bosch Gesellschaft für Medizinische Forschung mbH
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP