Phase 3
N=157
The Study Of Fluconazole For Vulvovaginal Candidiasis
Vulvovaginal Candidiasis
Bottom Line
View on ClinicalTrials.gov: NCT01806623 ↗Enrolled (actual)
157
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Therapeutic Outcome: Response Rate — 33.7; 54.2; 74.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fluconazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Pfizer
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Therapeutic Outcome: Response Rate |
33.7; 54.2; 74.7 | — |
| SECONDARY Clinical Efficacy: Cure Rate |
34.8; 57.3; 81.6 | — |
| SECONDARY Clinical Efficacy: Cure and Improvement Rate |
100.0; 99.0; 95.9 | — |
| SECONDARY Mycological Efficacy: Eradication Rate |
95.7; 89.8; 85.9 | — |
| SECONDARY Total Scores for Clinical Symptoms |
11.0; 4.5; 1.8; 0.8; 0.4 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) |
3.71 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
1.9 | — |
| SECONDARY Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
156.1 | — |
| SECONDARY Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight |
1.33 | — |
| SECONDARY Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight |
20.5 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight |
79.5 | — |
| SECONDARY Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid |
1.53 | — |
| SECONDARY Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid |
20.5 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid |
85.3 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01806623). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.