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

University of Southern Denmark (SDU)

Status: Completed

Conditions: Healthy

Treatments: Drug: Brentan (miconazole)

Study type: Interventional

Funder types: Other

Identifiers

NCT00668538

EudraCT 2008-000796-17

AKF-373

Details and patient eligibility

About

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).

Enrollment: 20 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)