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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Miconazole CYP1A2 CYP3A4 Women Healthy Subjects

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Brentan (miconazole)

Vaginal suppository 1200 mg at day 6

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

miconazole

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of Southern Denmark

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Odense, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

Kjaerstad MB, Nielsen F, Nohr-Jensen L, Zwisler S, Brosen K, Andersen HR. Systemic uptake of miconazole during vaginal suppository use and effect on CYP1A2 and CYP3A4 associated enzyme activities in women. Eur J Clin Pharmacol. 2010 Dec;66(12):1189-97. doi: 10.1007/s00228-010-0906-2. Epub 2010 Oct 6.

Reference Type DERIVED

PMID: 20924570 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EudraCT 2008-000796-17

Identifier Type: -

Identifier Source: secondary_id

AKF-373