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

April 25, 2008
October 16, 2008
April 2008
August 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00668538 on ClinicalTrials.gov Archive Site
Detection of miconazole or metabolites in blood and urine [ Time Frame: Blood and urine collected day 8 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Uptake of the Antifungal Miconazole and Effect on Estrogen Metabolizing Enzymes in Humans
Uptake of the Antifungal Miconazole and Effect on Estrogen Metabolizing Enzymes in Humans

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).

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
Drug: Brentan (miconazole)
Vaginal suppository 1200 mg at day 6
Other Name: miconazole
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00668538
AKF-373, EudraCT 2008-000796-17
Yes
Professor, M.D. Kim Brosen, University of Southern Denmark
University of Southern Denmark
Odense University Hospital
Not Provided
University of Southern Denmark
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP