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

This study is currently recruiting participants.
Verified February 2013 by Robert Bosch Gesellschaft für Medizinische Forschung mbH
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 7, 2013
Last verified: February 2013

February 2, 2011
February 7, 2013
December 2009
December 2013   (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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Clearance of Clomiphene and metabolites
  • Metabolomic [ Time Frame: 4, 8, 12 and 24 hours after drug application ] [ Designated as safety issue: No ]
    Metabolomic
  • Tmax of clomiphene [ Time Frame: 4, 8, 12, 24 hours after drug application ] [ Designated as safety issue: No ]
    Tmax of clomiphene and metabolites
  • Pharmacogenomics [ Time Frame: once ] [ Designated as safety issue: No ]
    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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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
    Other Name: clomiphene
  • Drug: clomiphene and paroxetine
    clomiphene 100mg and paroxetine 3x40mg
    Other Name: clomiphene and paroxetine
  • Drug: clomiphene and clarithromycin
    clomiphene 100mg and clarithromycin 9x500mg
    Other Name: clomiphene and clarithromycin
  • 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.
 
Recruiting
20
December 2013
December 2013   (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
Female
18 Years to 45 Years
Yes
Contact: Matthias Schwab, Prof. 0049 (0)71181013700 matthias.schwab@ikp-stuttgart.de
Germany
 
NCT01289756
IKP237, 2009-014531-20
No
Matthias Schwab, Robert Bosch Gesellschaft für Medizinische Forschung mbH
Robert Bosch Gesellschaft für Medizinische Forschung mbH
Not Provided
Not Provided
Robert Bosch Gesellschaft für Medizinische Forschung mbH
February 2013

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