Vulvovaginal CandidiasisPhase 3NCT01806623
The Study Of Fluconazole For Vulvovaginal Candidiasis
A Phase 3 study testing Fluconazole in people with Vulvovaginal Candidiasis, run by Pfizer at 10 sites in Japan.
Trial summary
As for the indication of vulvovaginal candidiasis, a single oral administration of fluconazole 150 mg has been approved and is recommended by guidelines overseas. However in Japan oral therapy with antifungal triazole such as Fluconazole has not been approved, and topical therapies such as vaginal tablets, pessary and… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Vulvovaginal Candidiasis
- What is being tested?
- Fluconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 10 sitesJapan
- Study dates
- 5 Mar 2013to 22 Nov 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinical symptoms and signs of vulvovaginal candidiasis.
- Patients tested positive for Candida by fungal culture.
- Patients who can agree not to have intercourse up to 28 days after dosing.
Who cannot join
- Patients with a history of hypersensitivity to fluconazole.
- Patients with severe renal dysfunction.
- Patients with liver disorder.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Japan10 sites
Ai WOMEN'S CLINIC
Asahikawa, Hokkaido, 070-8003
Mori Ladies Clinic
Fukuoka, 810-0011
IZUMI Ladies' Clinic
Gifu, 502-0914
Tetsu-Nakamura Obstetrics and Gynecology Department Internal Medicine
Kagoshima, 892-0845
Shirokane Ladies' Clinic
Minato-ku, Tokyo, 108-0071
Women's Clinic Kamimura
Okayama, 700-0901
Sutou Ladies Clinic
Osaka, 542-0081
Hayakawa Clinic
Osaka, 542-0086
Takane Medical Clinic
Shinagawa-ku, Tokyo, 140-0013
Suzuran Clinic
Suginami-ku, Tokyo, 167-0051
About this study
Official title: A Multicenter Open-label Non-comparative Study Of Fluconazole For The Treatment Of Vulvovaginal Candidiasis.
As for the indication of vulvovaginal candidiasis, a single oral administration of fluconazole 150 mg has been approved and is recommended by guidelines overseas. However in Japan oral therapy with antifungal triazole such as Fluconazole has not been approved, and topical therapies such as vaginal tablets, pessary and cream are used clinically. The purpose of this trial is to confirm the efficacy and safety of single oral administration of fluconazole 150 mg for the treatment of vulvovaginal candidiasis in Japanese patients.
- Conditions
- Vulvovaginal Candidiasis
- Being tested
- Fluconazole
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluconazoleDrug
Single oral dose of 150mg Fluconazole
| Study group | Role | What they receive |
|---|---|---|
| Fluconazole | Experimental | Not described Receives: Drug: Fluconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic Outcome: Response Rate
Therapeutic outcome was determined by combination of clinical efficacy and mycological efficacy for each participant as Effective, Ineffective or Indeterminate. The therapeutic outcome was considered as Effective when the clinical efficacy was Cure and the mycological efficacy was Eradication.
Primary evaluation of therapeutic outcome was on Day 28.
Response rate was calculated based on the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100.
Measured: Day 7, Day 14 and Day 28
Secondary outcomes (13)
Clinical Efficacy: Cure Rate
Scores of severity in signs and symptoms at each observation dates were compared with those before the treatment and the clinical efficacy was determined as Cure (the clinical symptom disappeared), Improvement (the clinical symptom was improved: the total score of clinical symptom was reduced relative to the total score before the treatment), Failure (the criteria for Cure and Improvement were not met, or other systemic antifungal drugs or local antifungal drugs were administered for the treatment of the disease to be examined) or Indeterminate (efficacy for each item was not determined for the reasons including failure to conduct the test, or other systemic antifungal agents or local antifungal drugs were administered for the treatment of infections other than the disease to be examined).
Cure rate was calculated based on the following formula, "the number of participants assessed as Cure" over "total participants excluding ones assessed as Indeterminate" multiplied by 100.
Measured: Day 7, Day 14 and Day 28
Clinical Efficacy: Cure and Improvement Rate
Scores of severity in signs and symptoms on each observation dates are compared with those before the treatment and the clinical efficacy is determined as Cure (the clinical symptom disappeared), Improvement (the clinical symptom was improved), Failure (the criteria for Cure and Improvement were not met, or other systemic antifungal drugs or local antifungal drugs were administered for the treatment of the disease to be examined) or Indeterminate (efficacy for each item was not determined for the reasons including failure to conduct the test, or other systemic antifungal agents or local antifungal drugs were administered for the treatment of infections other than the disease to be examined).
Cure and improvement rate was calculated based on the following formula, "the number of participants assessed as Cure or Improvement" over "total participants excluding ones assessed as Indeterminate" multiplied by 100.
Measured: Day 7, Day 14 and Day 28
Mycological Efficacy: Eradication Rate
Determined based on the results of culture of Candida as Eradication, Persistent or Indeterminate.
Eradication rate was calculated based on the following formula, "the number of participants assessed as Eradication" over "total participants excluding ones assessed as Indeterminate" multiplied by 100.
Measured: Day 7, Day 14 and Day 28
Total Scores for Clinical Symptoms
Sum of severity scores in vulvovaginal itching, vulvovaginal burning sensation, excoriation of vulva, vaginal discharge, vulva oedema, redness of vulva, vaginal redness, property of vaginal content. Higher scores show greater severity. Total Scores for Clinical Symptoms Severity range from 0 (best possible outcome) to 24 (worst possible outcome).
Measured: Day 1 (before dosing), Day 3, Day 7, Day 14 and Day 28
Maximum Observed Plasma Concentration (Cmax)
Measured: Before dosing and 2, 24, 48 and 168 hours after dosing
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: Before dosing and 2, 24, 48 and 168 hours after dosing
Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Measured: Before dosing and 2, 24, 48 and 168 hours after dosing
Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight
Measured: Before dosing and 2, 24, 48 and 168 hours after dosing
Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight
Measured: Before dosing and 2, 24, 48 and 168 hours after dosing
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight
Area under the concentration time-curve from zero to the last measured concentration (AUClast) for Vaginal Fluid Fluconazole Concentration adjusted by Sample Weight
Measured: Before dosing and 2, 24, 48 and 168 hours after dosing
Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid
Measured: Before dosing and 2, 24, 48 and 168 hours after dosing
Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid
Measured: Before dosing and 2, 24, 48 and 168 hours after dosing
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid
Area under the concentration time-curve from zero to the last measured concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid
Measured: Before dosing and 2, 24, 48 and 168 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study start5 Mar 2013
- Primary completion22 Nov 2013
- Study completion22 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vulvovaginal CandidiasisStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806623
- Sponsor's protocol ID
- A0561023
- Status last verified
- Jul 2021
- First submitted
- 28 Jan 2013
- Last updated
- 19 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mikamo H, Matsumizu M, Nakazuru Y, Okayama A, Nagashima M. Efficacy and safety of a single oral 150 mg dose of fluconazole for the treatment of vulvovaginal candidiasis in Japan. J Infect Chemother. 2015 Jul;21(7):520-6. doi: 10.1016/j.jiac.2015.03.011. Epub 2015 Mar 30.
PubMed 25887336
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Open-label Non-comparative Study Of Fluconazole For The Treatment Of Vulvovaginal Candidiasis.
- ClinicalTrials.gov ID
- NCT01806623
- Acronym / sponsor ID
- A0561023
- Conditions
- Vulvovaginal Candidiasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2013 (actual)
- Primary completion
- 22 Nov 2013 (actual)
- Study completion
- 22 Nov 2013 (actual)
- First posted
- 7 Mar 2013 (estimated)
- Results
- Posted 3 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As for the indication of vulvovaginal candidiasis, a single oral administration of fluconazole 150 mg has been approved and is recommended by guidelines overseas. However in Japan oral therapy with antifungal triazole such as Fluconazole has not been approved, and topical therapies such as vaginal tablets, pessary and cream are used clinically. The purpose of this trial is to confirm the efficacy and safety of single oral administration of fluconazole 150 mg for the treatment of vulvovaginal candidiasis in Japanese patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluconazole | Experimental | Drug: Fluconazole |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with clinical symptoms and signs of vulvovaginal candidiasis.
- Patients tested positive for Candida by fungal culture.
- Patients who can agree not to have intercourse up to 28 days after dosing.
Key exclusion criteria (3 listed)
- Patients with a history of hypersensitivity to fluconazole.
- Patients with severe renal dysfunction.
- Patients with liver disorder.
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 |
|---|---|---|
| FluconazoleSingle oral dose of 150mg Fluconazole | Drug | Fluconazole |
Primary outcome
Therapeutic Outcome: Response Rate
Time frame: Day 7, Day 14 and Day 28
Therapeutic outcome was determined by combination of clinical efficacy and mycological efficacy for each participant as Effective, Ineffective or Indeterminate. The therapeutic outcome was considered as Effective when the clinical efficacy was Cure and the mycological efficacy was Eradication. Primary evaluation of therapeutic outcome was on Day 28. Response rate was calculated based on the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100.
13 secondary outcomes
Clinical Efficacy: Cure Rate
Time frame: Day 7, Day 14 and Day 28
Clinical Efficacy: Cure and Improvement Rate
Time frame: Day 7, Day 14 and Day 28
Mycological Efficacy: Eradication Rate
Time frame: Day 7, Day 14 and Day 28
Total Scores for Clinical Symptoms
Time frame: Day 1 (before dosing), Day 3, Day 7, Day 14 and Day 28
Maximum Observed Plasma Concentration (Cmax)
Time frame: Before dosing and 2, 24, 48 and 168 hours after dosing
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Before dosing and 2, 24, 48 and 168 hours after dosing
Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: Before dosing and 2, 24, 48 and 168 hours after dosing
Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight
Time frame: Before dosing and 2, 24, 48 and 168 hours after dosing
Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight
Time frame: Before dosing and 2, 24, 48 and 168 hours after dosing
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight
Time frame: Before dosing and 2, 24, 48 and 168 hours after dosing
Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid
Time frame: Before dosing and 2, 24, 48 and 168 hours after dosing
Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid
Time frame: Before dosing and 2, 24, 48 and 168 hours after dosing
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid
Time frame: Before dosing and 2, 24, 48 and 168 hours after dosing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25887336Mikamo H, Matsumizu M, Nakazuru Y, Okayama A, Nagashima M. Efficacy and safety of a single oral 150 mg dose of fluconazole for the treatment of vulvovaginal candidiasis in Japan. J Infect Chemother. 2015 Jul;21(7):520-6. doi: 10.1016/j.jiac.2015.03.011. Epub 2015 Mar 30.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluconazole in people with Vulvovaginal Candidiasis, run by Pfizer at 10 sites in Japan.
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 3 inclusion and 3 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 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Japan. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Therapeutic Outcome: Response Rate (time frame: Day 7, Day 14 and Day 28). 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 NCT01806623, 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 19 Jul 2021.