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The Study Of Fluconazole For Vulvovaginal Candidiasis

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NCT01806623

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Ai WOMEN'S CLINIC
Asahikawa, Hokkaido, 070-8003 Japan
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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
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.

NCT01806623
Pfizer
Completed
The Study Of Fluconazole For Vulvovaginal Candidiasis

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The Study Of Fluconazole For Vulvovaginal Candidiasis
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.
Not Provided
Interventional
Phase 3
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Vulvovaginal Candidiasis
Drug: Fluconazole
Single oral dose of 150mg Fluconazole
Experimental: Fluconazole
Intervention: Drug: Fluconazole
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.
 
Completed
157
November 22, 2013
November 22, 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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:

  • Patients with a history of hypersensitivity to fluconazole.
  • Patients with severe renal dysfunction.
  • Patients with liver disorder.
Sexes Eligible for Study: Female
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01806623
A0561023
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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