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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00668538
• Other study ID #: AKF-373
• Secondary ID: EudraCT 2008-000
• Status: Completed
• Phase: N/A
• First received: April 25, 2008
• Last updated: October 16, 2008
• Start date: April 2008
• Est. completion date: August 2008

Study information

• Verified date: October 2008
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Brentan (miconazole)
Vaginal suppository 1200 mg at day 6

Locations

Country	Name	City	State
Denmark	Institute of Public Health, Clinical Pharmacology, University of Southern Denmark	Odense

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CYP1A2 and CYP3A4 activity measured as metabolite ratios of caffeine and quinidine, respectively		urine and blood collected day 4 and 8	No
Secondary	Detection of miconazole or metabolites in blood and urine		Blood and urine collected day 8	No