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

Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

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

Interventions

ClomipheneDRUG

clomiphene once 100 mg oral

clomiphene and paroxetineDRUG

clomiphene 100mg and paroxetine 3x40mg

clomiphene and clarithromycinDRUG

clomiphene 100mg and clarithromycin 9x500mg

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology and University of Tuebingen

Stuttgart, Baden-Wurttemberg, Germany

Outcomes

Primary Outcomes

Area under the plasma concentration versus time curve (AUC)of clomiphene

AUC of clomiphene and metabolites

Time frame: 1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after durg application

Peak Plasma Concentration (Cmax)of Clomiphene

Cmax of Clomiphene and metabolites

Time frame: 1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after drug application

Secondary Outcomes

Clearance of Clomiphene

Clearance of Clomiphene and metabolites

Time frame: 4, 8, 12 and 24 hours after drug application

Metabolomic

Time frame: 4, 8, 12 and 24 hours after drug application

Tmax of clomiphene

Tmax of clomiphene and metabolites

Time frame: 4, 8, 12, 24 hours after drug application

Pharmacogenomics

Time frame: once

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.