A Phase 3 interventional study of Dequalinium chloride and Clindamycin in Bacterial Vaginosis, sponsored by Medinova AG. Completed at 14 sites in 5 countries. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2010-05-18.
Sponsored by Medinova AG · Phase 3, Interventional, and Treatment
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.
220 studies on the registry are indexed under Vaginosis, Bacterial; 36 are open to participants now.
This study's enrollment of 321 is above the median of 100 across 187 interventional studies indexed under Vaginosis, Bacterial.
Browse Vaginosis, Bacterial studies →Medinova AG is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Dequalinium chloride
Drug: Clindamycin
Vaginal tablet, 10mg, 1 tablet daily for 6 days
vaginal cream, 2%, once daily for 7 days
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
Time frame: 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
Time frame: 4 weeks (on average)
Treatment failure
Treatment failures include non-responders and recurrences
Time frame: 4 weeks
Incidence of ADRs
Time frame: 4 weeks
This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.
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Medinova AG