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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
321
Vaginal tablet, 10mg, 1 tablet daily for 6 days
vaginal cream, 2%, once daily for 7 days
AZ Imelda Ziekenhuis
Bonheiden, Belgium
AZ St. Dimpna
Geel, Belgium
AZ Ziekenhuis Oost-Limburg
Genk, Belgium
clinical cure rate
Clinical cure rate based on Amsel criteria. For cure, clue cells have to be negative and not more than one of the other criteria positive
Time frame: 1 week (on average)
Clinical cure rate
Clinical cure rate based on Amsel criteria, where cure was defined as clue cells being negative and not more than one of the other criteria positive
Time frame: 4 weeks (on average)
Treatment failure
Treatment failures include non-responders and recurrences
Time frame: 4 weeks
Incidence of ADRs
Time frame: 4 weeks
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AZ Heilig Hart
Tienen, Belgium
Centrum Ambulantni gynekologie a prodnictvi
Brno, Czechia
Faculty Hospital Brno
Brno, Czechia
University Hospital Hradec Kralove
Hradec Králové, Czechia
Charles University
Prague, Czechia
Fakultni nemocnice Na Bulovce
Prague, Czechia
Ambulance pro gynekologie a prodnictvi
Telč, Czechia
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