Uptake of the Antifungal Miconazole and Effect on Estrogen Metabolizing Enzymes in Humans
Information source: University of Southern Denmark
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Brentan (miconazole) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Southern Denmark Overall contact:
Mia B Kjaerstad, cand scient, Phone: 45-29-898-969, Email: mbirkhoej@health.sdu.dk
Summary
The purpose with this study, is to study the uptake of the pharmaceutical antifungal
miconazole when used as a vaginal suppository in young women. We want to know if the uptake
is big enough to cause a biological effect (effect on CYP1A2 and CYP3A4 activity).
Clinical Details
Official title: Uptake of the Antifungal Miconazole and Effect on Estrogen Metabolizing Enzymes in Humans
Study design: Basic Science, Open Label, Single Group Assignment
Primary outcome: CYP1A2 and CYP3A4 activity measured as metabolite ratios of caffeine and quinidine, respectively
Secondary outcome: Detection of miconazole or metabolites in blood and urine
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
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
Locations and Contacts
Mia B Kjaerstad, cand scient, Phone: 45-29-898-969, Email: mbirkhoej@health.sdu.dk
Institute of Public Health, Clinical Pharmacology, University of Southern Denmark, Odense 5000 C, Denmark; Recruiting
Mia B Kjaerstad, cand scient, Phone: 45-29-898-969, Email: mbirkhoej@health.sdu.dk
Mia B Kjaerstad, cand scient, Sub-Investigator
Kim Brosen, M.D., Principal Investigator
Additional Information
Starting date: April 2008
Last updated: April 28, 2008
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