Trial | NCT01125410  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    321
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.
Study Started
Jan 31
2007
Primary Completion
Jul 31
2008
Study Completion
Feb 28
2009
Last Update
May 18
2010
Estimate

Drug Dequalinium chloride

Vaginal tablet, 10mg, 1 tablet daily for 6 days

Drug Clindamycin

vaginal cream, 2%, once daily for 7 days

Dequalinium chloride 10mg Experimental

clindamycin vaginal cream 2% Active Comparator

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
No Results Posted