NCT05788991

Comparison of Dequalinium Chloride (Fluomizin) vs Oral Metronidazole for the Treatment of Bacterial Vaginosis

Comparative Study of the Efficacy and Safety of Vaginally Applied Dequalinium Chloride (10 mg) and Orally Applied Metronidazole (2 x 500 mg) in the Treatment of Bacterial Vaginosis

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Medinova AG · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to show the efficacy and safety of dequalinium chloride in the treatment of bacterial vaginosis compared to metronidazole.

Detailed description

Eligible patients who signed informed consent were randomized to receive treatment with either dequalinium chloride (+ oral placebo) or metronidazole (+ vaginal placebo) for up to 7 days. Primary objective was clinical cure rate at one week after start of treatment. Control visits to assess outcomes were done after end of treatment and after one month.

Conditions

• Bacterial Vaginosis
• Vaginal Infection
• Vaginal Diseases

Interventions

Type	Name	Description
DRUG	Dequalinium Chloride	Fluomizin vaginal tablets (10 mg dequalinium chloride) used once a day for 6 days
DRUG	Metronidazole Oral	Metronidazole oral tablets (500 mg) taken twice a day for 7 days

Timeline

• Start date: 2021-07-26
• Primary completion: 2022-08-25
• Completion: 2022-08-25
• First posted: 2023-03-29
• Last updated: 2024-10-16
• Results posted: 2024-10-16

Locations

14 sites across 3 countries: Czechia, Poland, Slovakia