NCT01125410

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2007

Geographic Reach
5 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 18, 2010

Completed
Last Updated

May 18, 2010

Status Verified

May 1, 2010

Enrollment Period

1.5 years

First QC Date

May 11, 2010

Last Update Submit

May 17, 2010

Conditions

Bacterial Vaginosis

Keywords

FluomizinDequalinium chlorideBacterial vaginosisvaginal therapy

Outcome Measures

Primary Outcomes (2)

  • 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

    1 week (on average)

  • 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

    4 weeks (on average)

Secondary Outcomes (2)

  • Treatment failure

    4 weeks

  • Incidence of ADRs

    4 weeks

Study Arms (2)

Dequalinium chloride 10mg

EXPERIMENTAL
Drug: Dequalinium chloride

clindamycin vaginal cream 2%

ACTIVE COMPARATOR
Drug: Clindamycin

Interventions

Dequalinium chlorideDRUG

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

Dequalinium chloride 10mg
ClindamycinDRUG

vaginal cream, 2%, once daily for 7 days

clindamycin vaginal cream 2%

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of bacterial vaginosis
  • Women aged 18-55 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

AZ Imelda Ziekenhuis

Bonheiden, Belgium

Location

AZ St. Dimpna

Geel, Belgium

Location

AZ Ziekenhuis Oost-Limburg

Genk, Belgium

Location

AZ Heilig Hart

Tienen, Belgium

Location

Centrum Ambulantni gynekologie a prodnictvi

Brno, Czechia

Location

Faculty Hospital Brno

Brno, Czechia

Location

University Hospital Hradec Kralove

Hradec Králové, Czechia

Location

Charles University

Prague, Czechia

Location

Fakultni nemocnice Na Bulovce

Prague, Czechia

Location

Ambulance pro gynekologie a prodnictvi

Telč, Czechia

Location

LMU Munich

Munich, Germany

Location

JLF UK a MFN

Martin, Slovakia

Location

University Hospital of Geneva and Faculty of Medicine

Geneva, Switzerland

Location

CHUV

Lausanne, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 22205034DERIVED

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

DequaliniumClindamycin

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Quinolinium CompoundsQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLincomycinLincosamidesPyrrolidinesHeterocyclic Compounds, 1-RingGlycosidesCarbohydrates

Study Officials

  • Ernst Rainer Weissenbacher, MD

    Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, LMU Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 11, 2010

First Posted

May 18, 2010

Study Start

January 1, 2007

Primary Completion

July 1, 2008

Study Completion

February 1, 2009

Last Updated

May 18, 2010

Record last verified: 2010-05

Locations

CZ(6)BE(4)CH(2)DE(1)SL(1)