Title: A comparison of dequalinium chloride vaginal tablets (fluomizin®) and clindamycin vaginal cream in the treatment of bacterial vaginosis: a single-blind, randomized clinical trial of efficacy and safety
Authors: Weissenbacher, Ernst Rainer ×
Donders, Gilbert
Unzeitig, Vit
Martinez de Tejada, Begoña
Gerber, Stefan
Halaška, Michael
Spaček, Jiří #
Issue Date: 2012
Publisher: Karger
Series Title: Gynecologic and Obstetric Investigation vol:73 issue:1 pages:8-15
Abstract: Aims: To investigate if vaginal application of dequalinium chloride (DQC, Fluomizin®) is as effective as vaginal clindamycin (CLM) in the treatment of bacterial vaginosis (BV). Methods: This was a multinational, multicenter, single-blind, randomized trial in 15 centers, including 321 women. They were randomized to either vaginal DQC tablets or vaginal CLM cream. Follow-up visits were 1 week and 1 month after treatment. Clinical cure based on Amsel's criteria was the primary outcome. Secondary outcomes were rate of treatment failures and recurrences, incidence of post-treatment vulvovaginal candidosis (VVC), lactobacillary grade (LBG), total symptom score (TSC), and safety. Results: Cure rates with DQC (C1: 81.5%, C2: 79.5%) were as high as with CLM (C1: 78.4%, C2: 77.6%). Thus, the treatment with DQC had equal efficacy as CLM cream. A trend to less common post-treatment VVC in the DQC-treated women was observed (DQC: 2.5%, CLM: 7.7%; p = 0.06). Both treatments were well tolerated with no serious adverse events occurring. Conclusion: Vaginal DQC has been shown to be equally effective as CLM cream, to be well tolerated with no systemic safety concerns, and is therefore a valid alternative therapy for women with BV [, Med380104, NCT01125410].
ISSN: 0378-7346
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Department of Development and Regeneration - miscellaneous (+)
Medicine Teaching Programs
× corresponding author
# (joint) last author

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