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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:
Information provided by:
Medinova AG
ClinicalTrials.gov Identifier:
NCT01125410
First received: May 11, 2010
Last updated: May 17, 2010
Last verified: May 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

U.S. FDA Resources

Further study details as provided by Medinova AG:

Primary Outcome Measures:
  • clinical cure rate [ Time Frame: 1 week (on average) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Treatment failures include non-responders and recurrences

  • Incidence of ADRs [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Fakultni nemocnice Na Bulovce
Prague, Czech Republic
Charles University
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

No publications provided by Medinova AG

Additional 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
Study First Received: May 11, 2010
Last Updated: May 17, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Vaginosis, Bacterial
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Clindamycin
Clindamycin-2-phosphate
Dequalinium
 Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Anti-Infective Agents, Local

ClinicalTrials.gov processed this record on May 16, 2013