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

This study has been completed.

First Received on April 25, 2008. Last Updated on October 16, 2008 History of Changes

Sponsor:	University of Southern Denmark
Collaborator:	Odense University Hospital
Information provided by:	University of Southern Denmark
ClinicalTrials.gov Identifier:	NCT00668538

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:

Drug Information available for: Miconazole nitrate Miconazole Clotrimazole

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:

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):

Kjærstad MB, Nielsen F, Nøhr-Jensen L, Zwisler S, Brøsen 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. Epub 2010 Oct 6.

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
Miconazole
Clotrimazole
Estrogens
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012