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

This study has been completed.
Sponsor:
Collaborator:
Odense University Hospital
Information provided by:
University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT00668538
First received: April 25, 2008
Last updated: October 16, 2008
Last verified: October 2008
History of Changes
  Purpose

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).


Condition Intervention
Healthy
 Drug: Brentan (miconazole)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Uptake of the Antifungal Miconazole and Effect on Estrogen Metabolizing Enzymes in Humans

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • CYP1A2 and CYP3A4 activity measured as metabolite ratios of caffeine and quinidine, respectively [ Time Frame: urine and blood collected day 4 and 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Detection of miconazole or metabolites in blood and urine [ Time Frame: Blood and urine collected day 8 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: April 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Brentan (miconazole)
    Vaginal suppository 1200 mg at day 6
    Other Name: miconazole
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00668538

Locations
Denmark
Institute of Public Health, Clinical Pharmacology, University of Southern Denmark
Odense, Denmark, 5000 C
Sponsors and Collaborators
University of Southern Denmark
Odense University Hospital
  More Information

No publications provided by University of Southern Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Professor, M.D. Kim Brosen, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT00668538     History of Changes
Other Study ID Numbers: AKF-373, EudraCT 2008-000796-17
Study First Received: April 25, 2008
Last Updated: October 16, 2008
Health Authority: Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Southern Denmark:
Miconazole
CYP1A2
CYP3A4
Women
Healthy Subjects

Additional relevant MeSH terms:
Antifungal Agents
Clotrimazole
Miconazole
Estrogens
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Anti-Infective Agents, Local
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013