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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00668538

Enrollment

Registered

2008-04-29

Start date

2008-04-30

Completion date

2008-08-31

Last updated

2008-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Miconazole, CYP1A2, CYP3A4, Women, Healthy Subjects

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).

Interventions

DRUGBrentan (miconazole)

Vaginal suppository 1200 mg at day 6

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
CYP1A2 and CYP3A4 activity measured as metabolite ratios of caffeine and quinidine, respectively	urine and blood collected day 4 and 8

Secondary

Measure	Time frame
Detection of miconazole or metabolites in blood and urine	Blood and urine collected day 8

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026