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

May 11, 2010
May 17, 2010
January 2007
July 2008   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01125410 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Bacterial Vaginosis
  • Drug: Dequalinium chloride
    Vaginal tablet, 10mg, 1 tablet daily for 6 days
  • Drug: Clindamycin
    vaginal cream, 2%, once daily for 7 days
  • Experimental: Dequalinium chloride 10mg
    Intervention: Drug: Dequalinium chloride
  • Active Comparator: clindamycin vaginal cream 2%
    Intervention: Drug: Clindamycin
Weissenbacher ER, Donders G, Unzeitig V, Martinez de Tejada B, Gerber S, Halaška M, Špaček J; Fluomizin Study Group. A comparison of dequalinium chloride vaginal tablets (Fluomizin®) 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
321
February 2009
July 2008   (final data collection date for primary outcome measure)

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
Female
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   Germany,   Slovakia,   Switzerland
 
NCT01125410
Med380104
No
Dr. Philipp Grob, Medinova AG
Medinova AG
Not Provided
Principal Investigator: Ernst Rainer Weissenbacher, MD Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, LMU Munich
Medinova AG
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP