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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Bacterial Vaginosis

Intervention / Treatment
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* Drug: Dequalinium chloride
* Drug: Clindamycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dequalinium chloride 10mg<br> | Drug: Dequalinium chloride<br>* Vaginal tablet, 10mg, 1 tablet daily for 6 days<br>|
| Active Comparator: clindamycin vaginal cream 2%<br> | Drug: Clindamycin<br>* vaginal cream, 2%, once daily for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failure | Treatment failures include non-responders and recurrences | 4 weeks | 
| Incidence of ADRs |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluomizin, Dequalinium chloride, Bacterial vaginosis, vaginal therapy