NCT02180100

Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis

A Randomized, Parallel-group Study of Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Peking University Shenzhen Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 48 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg and fluconazole in the treatment of subjects with severe vulvovaginal candidiasis.

Detailed description

This study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppository 80 mg inserted intravaginally once daily before bedtime for 6 consecutive days and oral fluconazole 150mg at day 1 and day 4 in the treatment of subjects with severe vulvovaginal candidiasis.

Conditions

• Vulvovaginal Candidiasis

Interventions

Type	Name	Description
DRUG	Terconazole Vaginal Suppository	Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days
DRUG	Fluconazole	orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2014-07-02
• Last updated: 2020-10-23
• Results posted: 2020-10-23

Locations

1 site across 1 country: China