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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dequalinium chloride 10mg | Experimental |
| |
| clindamycin vaginal cream 2% | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dequalinium chloride | Drug | Vaginal tablet, 10mg, 1 tablet daily for 6 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment failure | Treatment failures include non-responders and recurrences | 4 weeks |
| Incidence of ADRs | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ernst Rainer Weissenbacher, MD | Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, LMU Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Imelda Ziekenhuis | Bonheiden | Belgium | ||||
| AZ St. Dimpna |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22205034 | Derived | 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. |
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| Clindamycin |
| Drug |
vaginal cream, 2%, once daily for 7 days |
|
| 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 |
| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D003868 | Dequalinium |
| D002981 | Clindamycin |
| ID | Term |
|---|---|
| D011806 | Quinolinium Compounds |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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