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

Anovulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289756
• Other study ID #: IKP237
• Secondary ID: 2009-014531-20
• Status: Completed
• Phase: Phase 1
• First received: February 2, 2011
• Last updated: February 23, 2015
• Start date: December 2009
• Est. completion date: November 2014

Study information

• Verified date: February 2015
• Source: Robert Bosch Gesellschaft für Medizinische Forschung mbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

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

Intervention

Drug:
• Clomiphene
clomiphene once 100 mg oral
• clomiphene and paroxetine
clomiphene 100mg and paroxetine 3x40mg
• clomiphene and clarithromycin
clomiphene 100mg and clarithromycin 9x500mg

Locations

Country	Name	City	State
Germany	Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology and University of Tuebingen	Stuttgart	BW

Sponsors (1)

Lead Sponsor	Collaborator
Robert Bosch Gesellschaft für Medizinische Forschung mbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration versus time curve (AUC)of clomiphene	AUC of clomiphene and metabolites	1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after durg application	No
Primary	Peak Plasma Concentration (Cmax)of Clomiphene	Cmax of Clomiphene and metabolites	1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after drug application	No
Secondary	Clearance of Clomiphene	Clearance of Clomiphene and metabolites	4, 8, 12 and 24 hours after drug application	No
Secondary	Metabolomic	Metabolomic	4, 8, 12 and 24 hours after drug application	No
Secondary	Tmax of clomiphene	Tmax of clomiphene and metabolites	4, 8, 12, 24 hours after drug application	No
Secondary	Pharmacogenomics	Pharmacogenomics	once	No