CompletedPhase 1

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

Germany20 participantsStarted 2009-12

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

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

Peak Plasma Concentration (Cmax)of Clomiphene

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

Trial details

NCT IDNCT01289756

SponsorRobert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-11

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