NCT02180828

Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis

An Case-controlled Randomized Study to the Efficacy of Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Peking University Shenzhen Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 48 Years
• Healthy volunteers: Not accepted

Summary

The study is focused to prove that the efficacy and safety of Clotrimazole vaginal tablet vs Fluconazole for the treatment of severe vulvovaginal candidiasis

Detailed description

The current study is evaluating both the efficacy and safety of the 2 doses of 500 mg clotrimazole vaginal tablet administered intravaginally( at day 1 and day 4) v.s 2 doses of 150 mg fluconazole( at day 1 and day 4) for treatment of severe vulvovaginal candidiasis.The number of participants with adverse events as a measure of safety and tolerability.

Conditions

• Candidiasis, Vulvovaginal

Interventions

Type	Name	Description
DRUG	Clotrimazole vaginal tablet	2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)
DRUG	Fluconazole	2 doses of 150 mg oral Fluconazole (at day1 and day4)

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2014-07-03
• Last updated: 2017-05-02
• Results posted: 2016-09-30

Locations

1 site across 1 country: China