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

Phase 4 Terminated 151 enrolled Medinova AG

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2021-07-26
Primary completion: 2022-08-25
Completion: 2022-08-25

Outcome

Met primary endpoint

Stopped (Enrollment): “Slow recruitment”

paper confirmed the noninferiority of dequalinium chloride. PMID 38696172 ↗

Publications

Results Raba G, Durkech A, Malik T, Bassfeld D, Grob P, Hurtado-Chong A; Fluomizin Study Group. Efficacy of Dequalinium Chloride vs Metronidazole for the Treatment of Bacterial Vaginosis: A Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e248661. doi: 10.1001/jamanetworkopen.2024.8661.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DEQUALINIUM	Small molecule	10 mg	Other
Comparator	Metronidazole	Small molecule	500 mg	Oral