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

University of Southern Denmark20 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Brentan (miconazole)DRUG

Vaginal suppository 1200 mg at day 6

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

Institute of Public Health, Clinical Pharmacology, University of Southern Denmark

Odense, Denmark

Outcomes

Primary Outcomes

CYP1A2 and CYP3A4 activity measured as metabolite ratios of caffeine and quinidine, respectively

Time frame: urine and blood collected day 4 and 8

Secondary Outcomes

Detection of miconazole or metabolites in blood and urine

Time frame: Blood and urine collected day 8

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.