NCT00803738

Safety and Equivalence of a Terconazole Vaginal Suppository (Test Product) Compared to the Reference Terconazole Vaginal Suppository in the Treatment of Vulvovaginal Candidiasis

A Multi-center, Randomized, Investigator-blinded, Parallel-group Study, Designed to Evaluate the Safety and Clinical Equivalence of Terconazole Vaginal Suppositories, 80 mg (Test Product) and Terconazole Vaginal Suppositories, 80 mg (Reference Product) in the Treatment of Vulvovaginal Candidiasis Caused by Candida Species

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 572 (actual)
• Sponsor: Padagis LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg(Test Product) and Terconazole Vaginal Suppositories, 80 mg(Reference Product) in the treatment of subjects with vulvovaginal candidiasis in order to establish bioequivalence.

Conditions

• Vulvovaginal Candidiasis

Interventions

Type	Name	Description
DRUG	Terconazole Vaginal Suppository	Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days
DRUG	Terazol Vaginal Suppository	Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days

Timeline

• Start date: 2002-12-01
• Primary completion: 2003-12-01
• Completion: 2003-12-01
• First posted: 2008-12-08
• Last updated: 2021-10-13
• Results posted: 2013-02-20