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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00668538
First Posted: April 29, 2008
Last Update Posted: October 17, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Odense University Hospital
Information provided by:
University of Southern Denmark
  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: None (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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: April 25, 2008
First Posted: April 29, 2008
Last Update Posted: October 17, 2008
Last Verified: October 2008

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

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