Anovulation, Cytochrome P450 CYP3A Enzyme Deficiency, Disorder Due Cytochrome P450 CYP2D6 Variant
Conditions
Keywords
pharmacokinetic, clomiphene, CYP2D6 polymorphisms, inhibition of CYP2D6 and CYP3A4
Brief 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.
Interventions
DRUGClomiphene
clomiphene once 100 mg oral
DRUGclomiphene and paroxetine
clomiphene 100mg and paroxetine 3x40mg
DRUGclomiphene and clarithromycin
clomiphene 100mg and clarithromycin 9x500mg
Sponsors
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC)of clomiphene | 1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after durg application | AUC of clomiphene and metabolites |
| Peak Plasma Concentration (Cmax)of Clomiphene | 1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after drug application | Cmax of Clomiphene and metabolites |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clearance of Clomiphene | 4, 8, 12 and 24 hours after drug application | Clearance of Clomiphene and metabolites |
| Metabolomic | 4, 8, 12 and 24 hours after drug application | Metabolomic |
| Tmax of clomiphene | 4, 8, 12, 24 hours after drug application | Tmax of clomiphene and metabolites |
| Pharmacogenomics | once | Pharmacogenomics |
Countries
Germany
Outcome results
None listed