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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01125410
Other study ID # Med380104
Secondary ID
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


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
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