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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01125410
Recruitment Status : Completed
First Posted : May 18, 2010
Last Update Posted : May 18, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Drug: Dequalinium chloride Drug: Clindamycin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 321 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Phase III Comparative Study of Efficacy of 10 mg Dequalinium Chloride (Fluomizin) in the Local Treatment of Bacterial Vaginosis
Study Start Date : January 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : February 2009

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

Primary Outcome Measures :
  1. clinical cure rate [ Time Frame: 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

  2. Clinical cure rate [ Time Frame: 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 :
  1. Treatment failure [ Time Frame: 4 weeks ]
    Treatment failures include non-responders and recurrences

  2. Incidence of ADRs [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01125410

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AZ Imelda Ziekenhuis
Bonheiden, Belgium
AZ St. Dimpna
Geel, Belgium
AZ Ziekenhuis Oost-Limburg
Genk, Belgium
AZ Heilig Hart
Tienen, Belgium
Czech Republic
Centrum Ambulantni gynekologie a prodnictvi
Brno, Czech Republic
Faculty Hospital Brno
Brno, Czech Republic
University Hospital Hradec Kralove
Hradec Kralove, Czech Republic
Charles University
Prague, Czech Republic
Fakultni nemocnice Na Bulovce
Prague, Czech Republic
Ambulance pro gynekologie a prodnictvi
Telc, Czech Republic
LMU Munich
Munich, Germany
Martin, Slovakia
University Hospital of Geneva and Faculty of Medicine
Geneva, Switzerland
Lausanne, Switzerland
Sponsors and Collaborators
Medinova AG
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Principal Investigator: Ernst Rainer Weissenbacher, MD Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, LMU Munich
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Philipp Grob, Medinova AG Identifier: NCT01125410    
Other Study ID Numbers: Med380104
First Posted: May 18, 2010    Key Record Dates
Last Update Posted: May 18, 2010
Last Verified: May 2010
Keywords provided by Medinova AG:
Dequalinium chloride
Bacterial vaginosis
vaginal therapy
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Vaginal Diseases
Bacterial Infections
Bacterial Infections and Mycoses
Clindamycin palmitate
Clindamycin phosphate
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local