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

This study has been completed.
Odense University Hospital
Information provided by:
University of Southern Denmark Identifier:
First received: April 25, 2008
Last updated: October 16, 2008
Last verified: October 2008
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
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:

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 ]

Secondary Outcome Measures:
  • Detection of miconazole or metabolites in blood and urine [ Time Frame: Blood and urine collected day 8 ]

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

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00668538

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Professor, M.D. Kim Brosen, University of Southern Denmark 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

Keywords provided by University of Southern Denmark:
Healthy Subjects

Additional relevant MeSH terms:
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Hormones processed this record on May 23, 2017