NCT01289756

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 4, 2011

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

February 24, 2015

Status Verified

February 1, 2015

Enrollment Period

4.9 years

First QC Date

February 2, 2011

Last Update Submit

February 23, 2015

Conditions

AnovulationDisorder Due Cytochrome P450 CYP2D6 VariantCytochrome P450 CYP3A Enzyme Deficiency

Keywords

pharmacokineticclomipheneCYP2D6 polymorphismsinhibition of CYP2D6 and CYP3A4

Outcome Measures

Primary Outcomes (2)

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

    AUC of clomiphene and metabolites

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

  • Peak Plasma Concentration (Cmax)of Clomiphene

    Cmax of Clomiphene and metabolites

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

Secondary Outcomes (4)

  • Clearance of Clomiphene

    4, 8, 12 and 24 hours after drug application

  • Metabolomic

    4, 8, 12 and 24 hours after drug application

  • Tmax of clomiphene

    4, 8, 12, 24 hours after drug application

  • Pharmacogenomics

    once

Study Arms (4)

CYP2D6 EM

EXPERIMENTAL

clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin

Drug: ClomipheneDrug: clomiphene and paroxetineDrug: clomiphene and clarithromycin

CYP2D6 IM

EXPERIMENTAL

clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin

Drug: ClomipheneDrug: clomiphene and paroxetineDrug: clomiphene and clarithromycin

CYP2D6 PM

EXPERIMENTAL

clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin

Drug: ClomipheneDrug: clomiphene and paroxetineDrug: clomiphene and clarithromycin

CYP2D6 UM

EXPERIMENTAL

clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin

Drug: ClomipheneDrug: clomiphene and paroxetineDrug: clomiphene and clarithromycin

Interventions

ClomipheneDRUG

clomiphene once 100 mg oral

CYP2D6 EMCYP2D6 IMCYP2D6 PMCYP2D6 UM
clomiphene and paroxetineDRUG

clomiphene 100mg and paroxetine 3x40mg

CYP2D6 EMCYP2D6 IMCYP2D6 PMCYP2D6 UM
clomiphene and clarithromycinDRUG

clomiphene 100mg and clarithromycin 9x500mg

CYP2D6 EMCYP2D6 IMCYP2D6 PMCYP2D6 UM

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Female caucasians
  • Age 18 - 45 years old
  • BMI 18.5 - 26 kg/m2

You may not qualify if:

  • Persons with known sensitivity of Clomifen and/or Paroxetine and/or Clarithromycin
  • Pregnancy/lactation period
  • Meno-/postmenopausal
  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Stuttgart, Baden-Wurttemberg, 70376, Germany

Location

MeSH Terms

Conditions

Anovulation

Interventions

ClomipheneParoxetineClarithromycin

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsErythromycinMacrolidesPolyketidesLactones

Study Officials

  • Matthias Schwab, Prof.

    Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. M.D.

Study Record Dates

First Submitted

February 2, 2011

First Posted

February 4, 2011

Study Start

December 1, 2009

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

February 24, 2015

Record last verified: 2015-02

Locations

DE(1)