Skip to main content
OpenTrials
Completed

NCT Number: NCT01289756

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anovulation Adnexal Diseases Cytochrome P450 CYP3A Enzyme Deficiency Disorder Due Cytochrome P450 CYP2D6 Variant Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

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

Stuttgart, Baden-Wurttemberg, 70376, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clomiphene

Drug

clomiphene once 100 mg oral

clomiphene and paroxetine

Drug

clomiphene 100mg and paroxetine 3x40mg

clomiphene and clarithromycin

Drug

clomiphene 100mg and clarithromycin 9x500mg

Primary outcomes

  1. 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

  2. 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 outcomes

  1. Clearance of Clomiphene

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

    Clearance of Clomiphene and metabolites

  2. Metabolomic

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

    Metabolomic

  3. Tmax of clomiphene

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

    Tmax of clomiphene and metabolites

  4. Pharmacogenomics

    Time frame: once

    Pharmacogenomics

Sponsors and collaborators

Lead sponsor

Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

Other

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Feb 4, 2011
Registry last updated
Feb 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.