NCT00668538

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Apr 2008

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

October 17, 2008

Status Verified

October 1, 2008

Enrollment Period

4 months

First QC Date

April 25, 2008

Last Update Submit

October 16, 2008

Conditions

Healthy

Keywords

MiconazoleCYP1A2CYP3A4WomenHealthy Subjects

Outcome Measures

Primary Outcomes (1)

  • CYP1A2 and CYP3A4 activity measured as metabolite ratios of caffeine and quinidine, respectively

    urine and blood collected day 4 and 8

Secondary Outcomes (1)

  • Detection of miconazole or metabolites in blood and urine

    Blood and urine collected day 8

Interventions

Brentan (miconazole)DRUG

Vaginal suppository 1200 mg at day 6

Also known as: miconazole

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Woman
  • Age 18-45 years
  • Healthy
  • Signed consent
  • Written authority to the GCP-unit

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Odense, 5000 C, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 20924570DERIVED

MeSH Terms

Interventions

Miconazole

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 25, 2008

First Posted

April 29, 2008

Study Start

April 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

October 17, 2008

Record last verified: 2008-10

Locations

DK(1)