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

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

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.

Study Overview

• Status: Completed
• Conditions: Bacterial Vaginosis
• Intervention / Treatment: Drug: Dequalinium chloride; Drug: Clindamycin

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 Type: Interventional
• Enrollment (Actual): 321
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Bonheiden, Belgium
    • AZ Imelda Ziekenhuis
  • Geel, Belgium
    • AZ St. Dimpna
  • Genk, Belgium
    • AZ Ziekenhuis Oost-Limburg
  • Tienen, Belgium
    • AZ Heilig Hart
• Czech Republic
  • Brno, Czech Republic
    • Centrum Ambulantni gynekologie a prodnictvi
  • Brno, Czech Republic
    • Faculty hospital Brno
  • Hradec Kralove, Czech Republic
    • University Hospital Hradec Kralove
  • Prague, Czech Republic
    • Charles University
  • Prague, Czech Republic
    • Fakultni nemocnice Na Bulovce
  • Telc, Czech Republic
    • Ambulance pro gynekologie a prodnictvi
• Germany
  • Munich, Germany
    • LMU Munich
• Slovakia
  • Martin, Slovakia
    • JLF UK a MFN
• Switzerland
  • Geneva, Switzerland
    • University Hospital of Geneva and Faculty of Medicine
  • Lausanne, Switzerland
    • CHUV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dequalinium chloride 10mg	Drug: Dequalinium chloride; Vaginal tablet, 10mg, 1 tablet daily for 6 days
Active Comparator: clindamycin vaginal cream 2%	Drug: Clindamycin; vaginal cream, 2%, once daily for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	4 weeks (on average)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment failure	Treatment failures include non-responders and recurrences	4 weeks
Incidence of ADRs		4 weeks

Collaborators and Investigators

• Sponsor: Medinova AG
• Investigators: Principal Investigator: Ernst Rainer Weissenbacher, MD, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, LMU Munich

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: May 11, 2010
• First Submitted That Met QC Criteria: May 17, 2010
• First Posted (Estimate): May 18, 2010

Study Record Updates

• Last Update Posted (Estimate): May 18, 2010
• Last Update Submitted That Met QC Criteria: May 17, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Fluomizin; Bacterial vaginosis; Dequalinium chloride; vaginal therapy
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Vaginal Diseases; Vaginosis, Bacterial; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Dequalinium
• Other Study ID Numbers: Med380104