Status:
COMPLETED
Uptake of the Antifungal Miconazole and Effect on Estrogen Metabolizing Enzymes in Humans
Lead Sponsor:
University of Southern Denmark
Collaborating Sponsors:
Odense University Hospital
Conditions:
Healthy
Eligibility:
FEMALE
18-45 years
Phase:
NA
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 eno...
Eligibility Criteria
Inclusion
- Woman
- Age 18-45 years
- Healthy
- Signed consent
- Written authority to the GCP-unit
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00668538
Start Date
April 1 2008
End Date
August 1 2008
Last Update
October 17 2008
Active Locations (1)
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1
Institute of Public Health, Clinical Pharmacology, University of Southern Denmark
Odense, Denmark, 5000 C