Comparative Study of Efficacy of 10 mg Dequalinium Chloride (Fluomizin) in the Local Treatment of Bacterial Vaginosis

Phase 3

Completed

• Conditions: Bacterial Vaginosis
• Interventions: Drug: Dequalinium chloride; Drug: Clindamycin

• Registration Number: NCT01125410
• Lead Sponsor: Medinova AG

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.

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2008-07
• Study Completion: 2009-02
• Status Verified: 2010-05
• Study First Submitted: 2010-05-11
• Study First Submitted QC: 2010-05-17
• Last Update Submitted: 2010-05-17
• Study First Posted: 2010-05-18
• Last Update Posted: 2010-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 321

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dequalinium chloride 10mg	Dequalinium chloride	-
clindamycin vaginal cream 2%	Clindamycin	-

Primary Outcome Measures

Name	Time	Method
clinical cure rate	1 week (on average)	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
Clinical cure rate	4 weeks (on average)	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

Secondary Outcome Measures

Name	Time	Method
Treatment failure	4 weeks	Treatment failures include non-responders and recurrences
Incidence of ADRs	4 weeks

Trial Locations

Locations (14)

AZ Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium

JLF UK a MFN; 🇸🇰 Martin, Slovakia

Charles University; 🇨🇿 Prague, Czech Republic

Centrum Ambulantni gynekologie a prodnictvi; 🇨🇿 Brno, Czech Republic

University Hospital of Geneva and Faculty of Medicine; 🇨🇭 Geneva, Switzerland

AZ St. Dimpna; 🇧🇪 Geel, Belgium

AZ Heilig Hart; 🇧🇪 Tienen, Belgium

AZ Imelda Ziekenhuis; 🇧🇪 Bonheiden, Belgium

Faculty Hospital Brno; 🇨🇿 Brno, Czech Republic

University Hospital Hradec Kralove; 🇨🇿 Hradec Kralove, Czech Republic

LMU Munich; 🇩🇪 Munich, Germany

Ambulance pro gynekologie a prodnictvi; 🇨🇿 Telc, Czech Republic

CHUV; 🇨🇭 Lausanne, Switzerland

Fakultni nemocnice Na Bulovce; 🇨🇿 Prague, Czech Republic