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

Sponsor

Medinova AG (Industry)

Overall Status

Completed

CT.gov ID

NCT01125410

Collaborator

(none)

321

Enrollment

Locations

Arms

Duration (Months)

22.9

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Vaginosis	Drug: Dequalinium chloride Drug: Clindamycin	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

321 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Jul 1, 2008

Actual Study Completion Date :

Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dequalinium chloride 10mg	Drug: Dequalinium chloride Vaginal tablet, 10mg, 1 tablet daily for 6 days
Active Comparator: clindamycin vaginal cream 2%	Drug: Clindamycin vaginal cream, 2%, once daily for 7 days

Arm

Intervention/Treatment

Experimental: Dequalinium chloride 10mg

Drug: Dequalinium chloride

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

Active Comparator: clindamycin vaginal cream 2%

Drug: Clindamycin

vaginal cream, 2%, once daily for 7 days

Outcome Measures

Primary Outcome Measures

clinical cure rate [1 week (on average)]
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 [4 weeks (on average)]
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 [4 weeks]
Treatment failures include non-responders and recurrences
Incidence of ADRs [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	AZ Imelda Ziekenhuis	Bonheiden	Belgium
2	AZ St. Dimpna	Geel	Belgium
3	AZ Ziekenhuis Oost-Limburg	Genk	Belgium
4	AZ Heilig Hart	Tienen	Belgium
5	Centrum Ambulantni gynekologie a prodnictvi	Brno	Czech Republic
6	Faculty Hospital Brno	Brno	Czech Republic
7	University Hospital Hradec Kralove	Hradec Kralove	Czech Republic
8	Charles University	Prague	Czech Republic
9	Fakultni nemocnice Na Bulovce	Prague	Czech Republic
10	Ambulance pro gynekologie a prodnictvi	Telc	Czech Republic
11	LMU Munich	Munich	Germany
12	JLF UK a MFN	Martin	Slovakia
13	University Hospital of Geneva and Faculty of Medicine	Geneva	Switzerland
14	CHUV	Lausanne	Switzerland