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

Last updated: May 17, 2010
Sponsor: Medinova AG
Overall Status: Completed

Phase

3

Condition

Gynecological Infections

Sexually Transmitted Diseases (Stds)

Vaginal Infection

Treatment

N/A

Clinical Study ID

NCT01125410
Med380104
  • Ages 18-55
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of bacterial vaginosis

  • Women aged 18-55 years

Exclusion

Exclusion Criteria:

  • Pregnancy or lactation

  • Uterine bleeding (including menstruation but not including cervical contact bleedingon 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 thestudy

Study Design

Total Participants: 321
Study Start date:
January 01, 2007
Estimated Completion Date:
February 28, 2009

Study 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.

Connect with a study center

  • AZ Imelda Ziekenhuis

    Bonheiden,
    Belgium

    Site Not Available

  • AZ St. Dimpna

    Geel,
    Belgium

    Site Not Available

  • AZ Ziekenhuis Oost-Limburg

    Genk,
    Belgium

    Site Not Available

  • AZ Heilig Hart

    Tienen,
    Belgium

    Site Not Available

  • Centrum Ambulantni gynekologie a prodnictvi

    Brno,
    Czech Republic

    Site Not Available

  • Faculty Hospital Brno

    Brno,
    Czech Republic

    Site Not Available

  • University Hospital Hradec Kralove

    Hradec Kralove,
    Czech Republic

    Site Not Available

  • Charles University

    Prague,
    Czech Republic

    Site Not Available

  • Fakultni nemocnice Na Bulovce

    Prague,
    Czech Republic

    Site Not Available

  • Ambulance pro gynekologie a prodnictvi

    Telc,
    Czech Republic

    Site Not Available

  • LMU Munich

    Munich,
    Germany

    Site Not Available

  • JLF UK a MFN

    Martin,
    Slovakia

    Site Not Available

  • University Hospital of Geneva and Faculty of Medicine

    Geneva,
    Switzerland

    Site Not Available

  • CHUV

    Lausanne,
    Switzerland

    Site Not Available

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