Clinical trial NCT01125410: Comparative Study of Efficacy of 10 mg Dequalinium Chloride (Fluomizin) in the Local Treatment of Bacterial Vaginosis
Official title: Phase III Comparative Study of Efficacy of 10 mg Dequalinium Chloride (Fluomizin) in the Local Treatment of Bacterial Vaginosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Vaginosis
Keywords: Fluomizin
Dequalinium chloride
Bacterial vaginosis
vaginal therapy
Lead sponsor: Medinova AG
Sponsor class: INDUSTRY
First posted: 2010-05-18
Enrollment: 321
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of bacterial vaginosis
* Women aged 18-55 years

Exclusion Criteria:

* Pregnancy or lactation
* Uterine bleeding (including menstruation but not including cervical contact bleeding on sampling) or vaginal bleeding of unknown origin
* Acute infections of the upper genital tract
* Clinical Symptoms of a vulvovaginal Candidiasis
* Use of anti-infectives (local or systemic) in the previous 14 days and/or during the study

Primary outcomes:
measure: clinical cure rate
timeFrame: 1 week (on average)
measure: Clinical cure rate
timeFrame: 4 weeks (on average)
Secondary outcomes:
measure: Treatment failure
timeFrame: 4 weeks
measure: Incidence of ADRs
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: AZ Imelda Ziekenhuis
city: Geel
country: Belgium
facility: AZ St. Dimpna
city: Genk
country: Belgium
facility: AZ Ziekenhuis Oost-Limburg
city: Tienen
country: Belgium
facility: AZ Heilig Hart
city: Brno
country: Czech Republic
facility: Centrum Ambulantni gynekologie a prodnictvi
city: Brno
country: Czech Republic
facility: Faculty Hospital Brno
city: Hradec Kralove
country: Czech Republic
facility: University Hospital Hradec Kralove
city: Prague
country: Czech Republic
facility: Charles University
city: Prague
country: Czech Republic
facility: Fakultni nemocnice Na Bulovce
city: Telc
country: Czech Republic
facility: Ambulance pro gynekologie a prodnictvi
city: Munich
country: Germany
facility: LMU Munich
city: Martin
country: Slovakia
facility: JLF UK a MFN
city: Geneva
country: Switzerland
facility: University Hospital of Geneva and Faculty of Medicine
city: Lausanne
country: Switzerland
facility: CHUV
Study officials:
affiliation: Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, LMU Munich
name: Ernst Rainer Weissenbacher, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weissenbacher ER, Donders G, Unzeitig V, Martinez de Tejada B, Gerber S, Halaska M, Spacek J; Fluomizin Study Group. A comparison of dequalinium chloride vaginal tablets (Fluomizin(R)) and clindamycin vaginal cream in the treatment of bacterial vaginosis: a single-blind, randomized clinical trial of efficacy and safety. Gynecol Obstet Invest. 2012;73(1):8-15. doi: 10.1159/000332398. Epub 2011 Dec 24.