search
Back to results

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

Primary Purpose

Bacterial Vaginosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dequalinium chloride
Clindamycin
Sponsored by
Medinova AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Vaginosis focused on measuring Fluomizin, Dequalinium chloride, Bacterial vaginosis, vaginal therapy

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • AZ Imelda Ziekenhuis
  • AZ St. Dimpna
  • AZ Ziekenhuis Oost-Limburg
  • AZ Heilig Hart
  • Centrum Ambulantni gynekologie a prodnictvi
  • Faculty Hospital Brno
  • University Hospital Hradec Kralove
  • Charles University
  • Fakultni nemocnice Na Bulovce
  • Ambulance pro gynekologie a prodnictvi
  • LMU Munich
  • JLF UK a MFN
  • University Hospital of Geneva and Faculty of Medicine
  • CHUV

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dequalinium chloride 10mg

clindamycin vaginal cream 2%

Arm Description

Outcomes

Primary Outcome Measures

clinical cure rate
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
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
Treatment failures include non-responders and recurrences
Incidence of ADRs

Full Information

First Posted
May 11, 2010
Last Updated
May 17, 2010
Sponsor
Medinova AG
search

1. Study Identification

Unique Protocol Identification Number
NCT01125410
Brief Title
Comparative Study of Efficacy of 10 mg Dequalinium Chloride (Fluomizin) in the Local Treatment of Bacterial Vaginosis
Official Title
Phase III Comparative Study of Efficacy of 10 mg Dequalinium Chloride (Fluomizin) in the Local Treatment of Bacterial Vaginosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medinova AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis
Keywords
Fluomizin, Dequalinium chloride, Bacterial vaginosis, vaginal therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
321 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dequalinium chloride 10mg
Arm Type
Experimental
Arm Title
clindamycin vaginal cream 2%
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dequalinium chloride
Intervention Description
Vaginal tablet, 10mg, 1 tablet daily for 6 days
Intervention Type
Drug
Intervention Name(s)
Clindamycin
Intervention Description
vaginal cream, 2%, once daily for 7 days
Primary Outcome Measure Information:
Title
clinical cure rate
Description
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
Time Frame
1 week (on average)
Title
Clinical cure rate
Description
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
Time Frame
4 weeks (on average)
Secondary Outcome Measure Information:
Title
Treatment failure
Description
Treatment failures include non-responders and recurrences
Time Frame
4 weeks
Title
Incidence of ADRs
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ernst Rainer Weissenbacher, MD
Organizational Affiliation
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, LMU Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Imelda Ziekenhuis
City
Bonheiden
Country
Belgium
Facility Name
AZ St. Dimpna
City
Geel
Country
Belgium
Facility Name
AZ Ziekenhuis Oost-Limburg
City
Genk
Country
Belgium
Facility Name
AZ Heilig Hart
City
Tienen
Country
Belgium
Facility Name
Centrum Ambulantni gynekologie a prodnictvi
City
Brno
Country
Czech Republic
Facility Name
Faculty Hospital Brno
City
Brno
Country
Czech Republic
Facility Name
University Hospital Hradec Kralove
City
Hradec Kralove
Country
Czech Republic
Facility Name
Charles University
City
Prague
Country
Czech Republic
Facility Name
Fakultni nemocnice Na Bulovce
City
Prague
Country
Czech Republic
Facility Name
Ambulance pro gynekologie a prodnictvi
City
Telc
Country
Czech Republic
Facility Name
LMU Munich
City
Munich
Country
Germany
Facility Name
JLF UK a MFN
City
Martin
Country
Slovakia
Facility Name
University Hospital of Geneva and Faculty of Medicine
City
Geneva
Country
Switzerland
Facility Name
CHUV
City
Lausanne
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
22205034
Citation
Weissenbacher ER, Donders G, Unzeitig V, Martinez de Tejada B, Gerber S, Halaska M, Spacek J; Fluomizin Study Group. A comparison of dequalinium chloride vaginal tablets (Fluomizin(R)) 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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs