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

Robert Bosch Gesellschaft für Medizinische Forschung mbH

Status and phase: Completed; Phase 1

Conditions: Anovulation; Disorder Due Cytochrome P450 CYP2D6 Variant; Cytochrome P450 CYP3A Enzyme Deficiency

Treatments: Drug: clomiphene and clarithromycin; Drug: Clomiphene; Drug: clomiphene and paroxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT01289756

2009-014531-20 (EudraCT Number)

IKP237

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

CYP2D6 EM

Experimental group

Description:

clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin

Treatment:

Drug: Clomiphene

Drug: clomiphene and paroxetine

Drug: clomiphene and clarithromycin

CYP2D6 IM

Experimental group

Description:

clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin

Treatment:

Drug: Clomiphene

Drug: clomiphene and paroxetine

Drug: clomiphene and clarithromycin

CYP2D6 PM

Experimental group

Description:

clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin

Treatment:

Drug: Clomiphene

Drug: clomiphene and paroxetine

Drug: clomiphene and clarithromycin

CYP2D6 UM

Experimental group

Description:

clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin

Treatment:

Drug: Clomiphene

Drug: clomiphene and paroxetine

Drug: clomiphene and clarithromycin