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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-08-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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Brentan (miconazole)

Vaginal suppository 1200 mg at day 6

Intervention Type DRUG

Other Intervention Names

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miconazole

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes