Bacterial Vaginosis
Conditions
Keywords
Fluomizin, Dequalinium chloride, Bacterial vaginosis, vaginal therapy
Brief 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.
Detailed 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.
Interventions
Vaginal tablet, 10mg, 1 tablet daily for 6 days
DRUGClindamycin
vaginal cream, 2%, once daily for 7 days
Sponsors
Medinova AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical cure rate | 1 week (on average) | 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 |
| Clinical cure rate | 4 weeks (on average) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment failure | 4 weeks | Treatment failures include non-responders and recurrences |
| Incidence of ADRs | 4 weeks | — |
Countries
Belgium, Czechia, Germany, Slovakia, Switzerland
Outcome results
None listed