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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
History of Changes
  Purpose

Aim of the study is the clinical validation of the metabolism and the pharmakokinetic of Clomifen in correlation to CYP2D6 and inhibition of CYP3A4.


Condition Intervention Phase
Anovulation
Disorder Due Cytochrome P450 CYP2D6 Variant
Cytochrome P450 CYP3A Enzyme Deficiency
 Drug: Clomiphene
Drug: clomiphene and paroxetine
Drug: clomiphene and clarithromycin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Influence of Pharmacogenetic Factors, Paroxetine and Clarithromycin on Pharmacokinetics of Clomiphene

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Robert Bosch Gesellschaft für Medizinische Forschung mbH:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 20
Study Start Date: December 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CYP2D6 EM
clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
 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 IM
clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
 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 PM
clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
 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 UM
clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
 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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289756

Contacts
Contact: Matthias Schwab, Prof. 0049 (0)71181013700 matthias.schwab@ikp-stuttgart.de

Locations
Germany
Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology and University of Tuebingen Recruiting
Stuttgart, BW, Germany, 70376
Contact: Matthias Schwab, Prof.     0049 (0)71181013700     matthias.schwab@ikp-stuttgart.de    
Principal Investigator: Matthias Schwab, Prof.            
Sponsors and Collaborators
Robert Bosch Gesellschaft für Medizinische Forschung mbH
  More Information

No publications provided

Responsible Party: Matthias Schwab, Prof. M.D., Robert Bosch Gesellschaft für Medizinische Forschung mbH
ClinicalTrials.gov Identifier: NCT01289756     History of Changes
Other Study ID Numbers: IKP237, 2009-014531-20
Study First Received: February 2, 2011
Last Updated: February 7, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Robert Bosch Gesellschaft für Medizinische Forschung mbH:
pharmacokinetic
clomiphene
CYP2D6 polymorphisms
inhibition of CYP2D6 and CYP3A4

Additional relevant MeSH terms:
Anovulation
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Clomiphene
Clarithromycin
Paroxetine
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
 Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on May 16, 2013