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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
151
Fluomizin vaginal tablets (10 mg dequalinium chloride) used once a day for 6 days
Metronidazole oral tablets (500 mg) taken twice a day for 7 days
Centrum ambulantní gynekologie a primární péče, s.r.o.
Brno, Czechia
G-CENTRUM Olomouc s.r.o.
Olomouc, Czechia
Gynekologicko-porodnická ambulance
Ústí nad Labem, Czechia
Clinical Cure Rate
Resolution of the abnormal vaginal discharge, negative whiff test, and less than 20% clue cells
Time frame: One week after randomization (C1)
Clinical Cure Rate
Resolution of the abnormal vaginal discharge, negative whiff test, and less than 20% clue cells
Time frame: One month after randomization (C2)
Bacteriological Cure Rate
Nugent score ≤3 Nugent score uses a 0 - 10 scale (higher score mean a worse outcome): 0 - 3 = normal flora, 4 - 6 = intermediate flora, 7 - 10 = bacterial vaginosis
Time frame: One week & one month
Therapeutic Cure
Combination of clinical and bacteriological cure
Time frame: One week & one month
Subjective Assessment of Efficacy
Efficacy was assessed by patients and investigators as 'very good', 'good', 'moderate' or 'poor'.
Time frame: One week
Subjective Assessment of Tolerability
Tolerability was assessed by patients as 'very good', 'good', 'moderate' or 'poor'.
Time frame: One week
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GYNEKO spol. s r.o
Vsetín, Czechia
Salve Medica Sp. z o. o. S. K.
Lodz, Poland
NZOZ All-Med Centrum Medyczne
Lodz, Poland
1 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
Lublin, Poland
KO-MED CENTRA KLINICZNE Sp. z o.o. Ośrodek
Lublin, Poland
Prywatny Gabinet Ginekologiczno-Położniczy
Żurawica, Poland
GPN, s.r.o.
Bratislava, Slovakia
...and 4 more locations