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ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Vulvovaginal Candidiasis
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Patients with a history of hypersensitivity to fluconazole.
- Patients with severe renal dysfunction.
- Patients with liver disorder.
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Vulvovaginal CandidiasisThe Study Of Fluconazole For Vulvovaginal Candidiasis
NCT01806623
- Asahikawa, Hokkaido
- Minato-ku, Tokyo
- Shinagawa-ku, Tokyo
- Suginami-ku, Tokyo
- Fukuoka,
- Gifu,
- Kagoshima,
- Okayama,
- Osaka,
- Osaka,
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | The Study Of Fluconazole For Vulvovaginal Candidiasis | |||
| Official Title ICMJE | A Multicenter Open-label Non-comparative Study Of Fluconazole For The Treatment Of Vulvovaginal Candidiasis. | |||
| Brief 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 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Vulvovaginal Candidiasis | |||
| Intervention ICMJE | Drug: Fluconazole
Single oral dose of 150mg Fluconazole | |||
| Study Arms ICMJE | Experimental: Fluconazole
Intervention: Drug: Fluconazole | |||
| 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 157 | |||
| Original Estimated Enrollment ICMJE | 130 | |||
| Actual Study Completion Date ICMJE | November 22, 2013 | |||
| Actual Primary Completion Date | November 22, 2013 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Japan | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01806623 | |||
| Other Study ID Numbers ICMJE | A0561023 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | March 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||