Phase III Comparative Study of Efficacy of 10 mg Dequalinium Chloride (Fluomizin) in the Local Treatment of Bacterial Vaginosis
| Registry | NCT01125410 |
|---|---|
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 321 (Actual) |
| Sponsor | Medinova AG (Industry) |
| Conditions | Bacterial Vaginosis |
| Interventions | Dequalinium chloride, Clindamycin (Drug) |
| Dates | start 2007-01-01, primary completion 2008-07-01, completion 2009-02-01, first posted 2010-05-18, last updated 2010-05-18 |
| Locations | 14 sites in Belgium, Czechia, Germany, Slovakia, Switzerland |
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All trials for Bacterial Vaginosis All trials of Dequalinium chloride All trials of Clindamycin
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Dequalinium chloride 10mg | Experimental | Drug: Dequalinium chloride | |
| clindamycin vaginal cream 2% | Active comparator | Drug: Clindamycin |
Sex: Female, ages: 18 Years to 55 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| AZ Imelda Ziekenhuis | Bonheiden | Belgium | |
| AZ St. Dimpna | Geel | Belgium | |
| AZ Ziekenhuis Oost-Limburg | Genk | Belgium | |
| AZ Heilig Hart | Tienen | Belgium | |
| Centrum Ambulantni gynekologie a prodnictvi | Brno | Czechia | |
| Faculty Hospital Brno | Brno | Czechia | |
| University Hospital Hradec Kralove | Hradec Králové | Czechia | |
| Charles University | Prague | Czechia | |
| Fakultni nemocnice Na Bulovce | Prague | Czechia | |
| Ambulance pro gynekologie a prodnictvi | Telč | Czechia | |
| LMU Munich | Munich | Germany | |
| JLF UK a MFN | Martin | Slovakia | |
| University Hospital of Geneva and Faculty of Medicine | Geneva | Switzerland | |
| CHUV | Lausanne | Switzerland |