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

NCT ID: NCT01289756

Last Updated: 2015-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2014-11-30

Brief Summary

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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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CYP2D6 EM

clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin

Group Type EXPERIMENTAL

Clomiphene

Intervention Type DRUG

clomiphene once 100 mg oral

clomiphene and paroxetine

Intervention Type DRUG

clomiphene 100mg and paroxetine 3x40mg

clomiphene and clarithromycin

Intervention Type DRUG

clomiphene 100mg and clarithromycin 9x500mg

CYP2D6 IM

clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin

Group Type EXPERIMENTAL

Clomiphene

Intervention Type DRUG

clomiphene once 100 mg oral

clomiphene and paroxetine

Intervention Type DRUG

clomiphene 100mg and paroxetine 3x40mg

clomiphene and clarithromycin

Intervention Type DRUG

clomiphene 100mg and clarithromycin 9x500mg

CYP2D6 PM

clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin

Group Type EXPERIMENTAL

Clomiphene

Intervention Type DRUG

clomiphene once 100 mg oral

clomiphene and paroxetine

Intervention Type DRUG

clomiphene 100mg and paroxetine 3x40mg

clomiphene and clarithromycin

Intervention Type DRUG

clomiphene 100mg and clarithromycin 9x500mg

CYP2D6 UM

clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin

Group Type EXPERIMENTAL

Clomiphene

Intervention Type DRUG

clomiphene once 100 mg oral

clomiphene and paroxetine

Intervention Type DRUG

clomiphene 100mg and paroxetine 3x40mg

clomiphene and clarithromycin

Intervention Type DRUG

clomiphene 100mg and clarithromycin 9x500mg

Interventions

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Clomiphene

clomiphene once 100 mg oral

Intervention Type DRUG

clomiphene and paroxetine

clomiphene 100mg and paroxetine 3x40mg

Intervention Type DRUG

clomiphene and clarithromycin

clomiphene 100mg and clarithromycin 9x500mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

OTHER

Sponsor Role lead

Responsible Party

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Matthias Schwab

Prof. M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthias Schwab, Prof.

Role: PRINCIPAL_INVESTIGATOR

Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology

Locations

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

Stuttgart, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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2009-014531-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IKP237

Identifier Type: -

Identifier Source: org_study_id

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