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

Information source: University of Southern Denmark
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Brentan (miconazole) (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Southern Denmark

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).

Clinical Details

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

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

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

Secondary outcome: Detection of miconazole or metabolites in blood and urine

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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

Locations and Contacts

Institute of Public Health, Clinical Pharmacology, University of Southern Denmark, Odense 5000 C, Denmark
Additional Information

Starting date: April 2008
Last updated: October 16, 2008

Page last updated: August 23, 2015

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