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

NCT01125410 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 321

Last updated 2010-05-18

No results posted yet for this 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.

Conditions

  • Bacterial Vaginosis

Interventions

DRUG

Dequalinium chloride

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

DRUG

Clindamycin

vaginal cream, 2%, once daily for 7 days

Sponsors & Collaborators

  • Medinova AG

    lead INDUSTRY

Principal Investigators

  • Ernst Rainer Weissenbacher, MD · Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, LMU Munich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-07-31
Completion
2009-02-28

Countries

  • Belgium
  • Czechia
  • Germany
  • Slovakia
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01125410 on ClinicalTrials.gov