Uptake of the Antifungal Miconazole and Effect on Estrogen Metabolizing Enzymes in Humans
This study has been completed.
Sponsor:
University of Southern Denmark
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
| Tracking Information | |
|---|---|
| First Received Date ICMJE | April 25, 2008 |
| Last Updated Date | October 16, 2008 |
| Start Date ICMJE | April 2008 |
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
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 ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00668538 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
Detection of miconazole or metabolites in blood and urine [ Time Frame: Blood and urine collected day 8 ] [ Designated as safety issue: No ] |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | |
| Original Other Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Uptake of the Antifungal Miconazole and Effect on Estrogen Metabolizing Enzymes in Humans |
| Official Title ICMJE | Uptake of the Antifungal Miconazole and Effect on Estrogen Metabolizing Enzymes in Humans |
| Brief Summary | 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). |
| Detailed Description | |
| Study Type ICMJE | Interventional |
| Study Phase | |
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Condition ICMJE | Healthy |
| Intervention ICMJE | Drug: Brentan (miconazole)
Vaginal suppository 1200 mg at day 6
Other Name: miconazole |
| Study Arm (s) | |
| Publications * | 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. |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 20 |
| Completion Date | August 2008 |
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Female |
| Ages | 18 Years to 45 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Denmark |
| Administrative Information | |
| NCT Number ICMJE | NCT00668538 |
| Other Study ID Numbers ICMJE | AKF-373, EudraCT 2008-000796-17 |
| Has Data Monitoring Committee | Yes |
| Responsible Party | Professor, M.D. Kim Brosen, University of Southern Denmark |
| Study Sponsor ICMJE | University of Southern Denmark |
| Collaborators ICMJE | Odense University Hospital |
| Investigators ICMJE | |
| Information Provided By | University of Southern Denmark |
| Verification Date | October 2008 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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