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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01125410
First Posted: May 18, 2010
Last Update Posted: May 18, 2010
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.
Information provided by:
Medinova AG
  Purpose
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 Intervention Phase
Bacterial Vaginosis Drug: Dequalinium chloride Drug: Clindamycin Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Medinova AG:

Primary Outcome Measures:
  • 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

  • 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:
  • Treatment failure [ Time Frame: 4 weeks ]
    Treatment failures include non-responders and recurrences

  • Incidence of ADRs [ Time Frame: 4 weeks ]

Enrollment: 321
Study Start Date: January 2007
Study Completion Date: February 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01125410


Locations
Belgium
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
Germany
LMU Munich
Munich, Germany
Slovakia
JLF UK a MFN
Martin, Slovakia
Switzerland
University Hospital of Geneva and Faculty of Medicine
Geneva, Switzerland
CHUV
Lausanne, Switzerland
Sponsors and Collaborators
Medinova AG
Investigators
Principal Investigator: Ernst Rainer Weissenbacher, MD Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, LMU Munich
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Philipp Grob, Medinova AG
ClinicalTrials.gov Identifier: NCT01125410     History of Changes
Other Study ID Numbers: Med380104
First Submitted: May 11, 2010
First Posted: May 18, 2010
Last Update Posted: May 18, 2010
Last Verified: May 2010

Keywords provided by Medinova AG:
Fluomizin
Dequalinium chloride
Bacterial vaginosis
vaginal therapy

Additional relevant MeSH terms:
Vaginal Diseases
Vaginosis, Bacterial
Genital Diseases, Female
Bacterial Infections
Vaginitis
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Dequalinium
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local