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Completed

NCT Number: NCT00668538

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

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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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Odense, 5000 C, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brentan (miconazole)

Drug

Vaginal suppository 1200 mg at day 6

Other names: miconazole

Primary outcomes

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

    Time frame: urine and blood collected day 4 and 8

Secondary outcomes

  1. Detection of miconazole or metabolites in blood and urine

    Time frame: Blood and urine collected day 8

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Odense University Hospital

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 29, 2008
Registry last updated
Oct 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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