Uptake of the Antifungal Miconazole and Effect on Estroge... | NCT00668538

Studies
Uptake of the Antifungal Miconazole and Effect on Estrogen Metabolizing Enzymes in Humans

NCT00668538

Sponsor

University of Southern Denmark

Status

Completed

Last Update Posted

Oct 17, 2008Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Brentan (miconazole)

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT 2008-000796-17

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Apr 25, 2008

First Submission Date that Met QC Criteria

Apr 28, 2008

First Posted Date

Apr 29, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2008

Last Update Posted Date

Oct 17, 2008Estimated

Name	Class
Odense University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study, is to study the uptake of the pharmaceutical antifungal miconazole when used as a vaginal suppository in young women. The investigators want to know if the uptake is big enough to cause a biological effect (effect on CYP1A2 and CYP3A4 activity).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brentan (miconazole)	Drug	Vaginal suppository 1200 mg at day 6		miconazole

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CYP1A2 and CYP3A4 activity measured as metabolite ratios of caffeine and quinidine, respectively		urine and blood collected day 4 and 8

Secondary Outcomes

Measure	Description	Time Frame
Detection of miconazole or metabolites in blood and urine		Blood and urine collected day 8

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Woman
Age 18-45 years
Healthy
Signed consent
Written authority to the GCP-unit

Exclusion Criteria:

Pregnancy
Breast-feeding
Hypersensitivity to miconazole
Hypersensitivity to sodium ethyl parahydroxybenzoic acid(E219)
Hypersensitivity to sodium propyl parahydroxybenzoic acid (E217)
Using contraceptives with hormones
Daily consumption of alcohol
Daily use of medicine
Participated in a clinical trial within the last 3 months

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Public Health, Clinical Pharmacology, University of Southern Denmark		Odense		5000 C	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20924570	Derived	Kjaerstad MB, Nielsen F, Nohr-Jensen L, Zwisler S, Brosen K, Andersen HR. Systemic uptake of miconazole during vaginal suppository use and effect on CYP1A2 and CYP3A4 associated enzyme activities in women. Eur J Clin Pharmacol. 2010 Dec;66(12):1189-97. doi: 10.1007/s00228-010-0906-2. Epub 2010 Oct 6.

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds