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

Bacterial Vaginosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01125410
• Other study ID #: Med380104
• Status: Completed
• Phase: Phase 3
• First received: May 11, 2010
• Last updated: May 17, 2010
• Start date: January 2007
• Est. completion date: February 2009

Study information

• Verified date: May 2010
• Source: Medinova AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: February 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• Dequalinium chloride
Vaginal tablet, 10mg, 1 tablet daily for 6 days
• Clindamycin
vaginal cream, 2%, once daily for 7 days

Locations

Country	Name	City	State
Belgium	AZ Imelda Ziekenhuis	Bonheiden
Belgium	AZ St. Dimpna	Geel
Belgium	AZ Ziekenhuis Oost-Limburg	Genk
Belgium	AZ Heilig Hart	Tienen
Czech Republic	Centrum Ambulantni gynekologie a prodnictvi	Brno
Czech Republic	Faculty Hospital Brno	Brno
Czech Republic	University Hospital Hradec Kralove	Hradec Kralove
Czech Republic	Charles University	Prague
Czech Republic	Fakultni nemocnice Na Bulovce	Prague
Czech Republic	Ambulance pro gynekologie a prodnictvi	Telc
Germany	LMU Munich	Munich
Slovakia	JLF UK a MFN	Martin
Switzerland	University Hospital of Geneva and Faculty of Medicine	Geneva
Switzerland	CHUV	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Medinova AG

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Germany,  Slovakia,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Secondary	Treatment failure	Treatment failures include non-responders and recurrences	4 weeks	No
Secondary	Incidence of ADRs		4 weeks	Yes