Uptake of the Antifungal Miconazole and Effect on Estrogen Metabolizing Enzymes in Humans
Not Applicable
Completed
- Conditions
- Healthy
- Registration Number
- NCT00668538
- Lead Sponsor
- University of Southern Denmark
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method CYP1A2 and CYP3A4 activity measured as metabolite ratios of caffeine and quinidine, respectively urine and blood collected day 4 and 8
- Secondary Outcome Measures
Name Time Method Detection of miconazole or metabolites in blood and urine Blood and urine collected day 8
Trial Locations
- Locations (1)
Institute of Public Health, Clinical Pharmacology, University of Southern Denmark
🇩🇰Odense, Denmark