NCT01125410

Comparative Study of Efficacy of 10 mg Dequalinium Chloride (Fluomizin) in the Local Treatment of Bacterial Vaginosis

Phase III Comparative Study of Efficacy of 10 mg Dequalinium Chloride (Fluomizin) in the Local Treatment of Bacterial Vaginosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 321 (actual)
• Sponsor: Medinova AG · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study was to evaluate whether vaginal tablets containing 10 mg dequalinium chloride (Fluomizin) are comparable in clinical efficacy and safety to clindamycin vaginal cream (2%) in patients suffering from bacterial vaginosis.

Detailed description

An international, multi-center, single-blind, randomized, active-controlled study with two parallel groups in patients with bacterial vaginosis. Eligible patients were randomized to receive Fluomizin vaginal tablets for 6 days or Clindamycin vaginal cream (2%) for 7 days. Control examinations were performed 3 to 14 days and 2 to 6 weeks after the end of the therapy.

Conditions

• Bacterial Vaginosis

Interventions

Type	Name	Description
DRUG	Dequalinium chloride	Vaginal tablet, 10mg, 1 tablet daily for 6 days
DRUG	Clindamycin	vaginal cream, 2%, once daily for 7 days

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-07-01
• Completion: 2009-02-01
• First posted: 2010-05-18
• Last updated: 2010-05-18

Locations

14 sites across 5 countries: Belgium, Czechia, Germany, Slovakia, Switzerland