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

October 16, 2008 updated by: University of Southern Denmark
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000 C
        • Institute of Public Health, Clinical Pharmacology, University of Southern Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

August 1, 2008

Study Completion (ACTUAL)

August 1, 2008

Study Registration Dates

First Submitted

April 25, 2008

First Submitted That Met QC Criteria

April 28, 2008

First Posted (ESTIMATE)

April 29, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 17, 2008

Last Update Submitted That Met QC Criteria

October 16, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKF-373
  • EudraCT 2008-000796-17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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