Uptake of the Antifungal Miconazole and Effect on Estrogen Metabolizing Enzymes in Humans

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Southern Denmark
• Collaborator: Odense University Hospital
• Treatments: Antifungal Agents; Clotrimazole; Estrogens; Miconazole

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