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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
  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
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:


Further study details as provided by Matthias Schwab, 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 ]
    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


Secondary Outcome Measures:
  • 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


Enrollment: 20
Study Start Date: December 2009
Study Completion Date: November 2014
Primary Completion Date: November 2014 (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
Drug: clomiphene and paroxetine
clomiphene 100mg and paroxetine 3x40mg
Drug: clomiphene and clarithromycin
clomiphene 100mg and clarithromycin 9x500mg
Experimental: CYP2D6 IM
clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
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 PM
clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
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 UM
clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289756

Locations
Germany
Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology and University of Tuebingen
Stuttgart, BW, Germany, 70376
Sponsors and Collaborators
Robert Bosch Gesellschaft für Medizinische Forschung mbH
Investigators
Principal Investigator: Matthias Schwab, Prof. Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology
  More Information

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 ( EudraCT Number )
Study First Received: February 2, 2011
Last Updated: February 23, 2015

Keywords provided by Matthias Schwab, 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
Clarithromycin
Paroxetine
Clomiphene
Enclomiphene
Zuclomiphene
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Estrogen Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on July 21, 2017