HealthyNCT00668538
Uptake of the Antifungal Miconazole and Effect on Estrogen Metabolizing Enzymes in Humans
A study testing Brentan (miconazole) in people with Healthy, run by University of Southern Denmark at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Brentan (miconazole)
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2008to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Woman
- Age 18-45 years
- Healthy
- Signed consent
- Written authority to the GCP-unit
Who cannot join
- Pregnancy
- Breast-feeding
- Hypersensitivity to miconazole
- Hypersensitivity to sodium ethyl parahydroxybenzoic acid(E219)
- Hypersensitivity to sodium propyl parahydroxybenzoic acid (E217)
- Using contraceptives with hormones
Show all 9Show fewer
- Daily consumption of alcohol
- Daily use of medicine
- Participated in a clinical trial within the last 3 months
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Public Health, Clinical Pharmacology, University of Southern Denmark
Odense, 5000 C
About this study
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).
- Conditions
- Healthy
- Being tested
- Brentan (miconazole)
- Keywords
- Miconazole, CYP1A2, CYP3A4, Women, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brentan (miconazole)Drug
Also called miconazole
Vaginal suppository 1200 mg at day 6
What is being measured
The primary outcome is the main question the study is designed to answer.
CYP1A2 and CYP3A4 activity measured as metabolite ratios of caffeine and quinidine, respectively
Measured: urine and blood collected day 4 and 8
Secondary outcomes (1)
Detection of miconazole or metabolites in blood and urine
Measured: Blood and urine collected day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668538
- Sponsor's protocol ID
- AKF-373
- Other IDs
- EudraCT 2008-000796-17
- Status last verified
- Oct 2008
- First submitted
- 25 Apr 2008
- Last updated
- 17 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20924570
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uptake of the Antifungal Miconazole and Effect on Estrogen Metabolizing Enzymes in Humans
- ClinicalTrials.gov ID
- NCT00668538
- Acronym / sponsor ID
- AKF-373
- Conditions
- Healthy
- Keywords
- Miconazole, CYP1A2, CYP3A4, Women, Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- Apr 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 29 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Woman
- Age 18-45 years
- Healthy
- Signed consent
- Written authority to the GCP-unit
Key exclusion criteria (9 listed)
- Pregnancy
- Breast-feeding
- Hypersensitivity to miconazole
- Hypersensitivity to sodium ethyl parahydroxybenzoic acid(E219)
- Hypersensitivity to sodium propyl parahydroxybenzoic acid (E217)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brentan (miconazole)Also: miconazoleVaginal suppository 1200 mg at day 6 | Drug | – |
Primary outcome
CYP1A2 and CYP3A4 activity measured as metabolite ratios of caffeine and quinidine, respectively
Time frame: urine and blood collected day 4 and 8
1 secondary outcome
Detection of miconazole or metabolites in blood and urine
Time frame: Blood and urine collected day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2008.
- Derived from this study: PubMed 20924570Kjaerstad 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brentan (miconazole) in people with Healthy, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CYP1A2 and CYP3A4 activity measured as metabolite ratios of caffeine and quinidine, respectively (time frame: urine and blood collected day 4 and 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00668538, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2008.