NCT02713139

Efficacy and Safety of the Association of Clotrimazole and Metronidazole in the Treatment of Vaginal Discharge From Different Etiologies.

Phase III, Multicenter, Randomized, Parallel, Open Label, Controlled and Comparative Study to Evaluate the Efficacy and Safety of the Association of Clotrimazole 200mg and Metronidazole 0,75% (Colpistatin 5DT®) Compared to Gynecological Flagyl®(Metronidazole 100mg/g) and the Vaginal Cream Gino-Canesten® 3 (Clotrimazole 20mg/g) in the Syndromic Treatment of the Vaginal Discharge From Different Etiologies.

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ache Laboratorios Farmaceuticos S.A. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy and safety of the association clotrimazole 200mg and metronidazole 0,75%(Clopistatin 5DT®) and whether it is superior when compared with metronidazole 100mg/g (gynecologic Flagyl®) and clotrimazole 20mg/g (Gino-Canesten® 3) in the syndromic treatment of vaginal discharge from different etiologies.

Conditions

• Sexual Active Women
• Vaginal Discharge

Interventions

Type	Name	Description
DRUG	Clotrimazole + Metronidazole	Vaginal cream with Clotrimazole 200mg and Metronidazole 0,75%. Apply once per day, before bedtime, for 5 (five) days.
DRUG	Metronidazole	Vaginal gel with Metronifdazole 100mg/g. Apply once per day, before bedtime, for 10(ten) days.
DRUG	Clotrimazole	Vaginal cream with Clotrimazole 20mg/g. Apply once per day, before bedtime, for 3 (three) days.

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-03-01
• First posted: 2016-03-18
• Last updated: 2016-03-18