Vaginosis, Bacterial Clinical Trial
Official title:
Medical Device Matuzalem Flavonoid Tea Extract Vaginal Ovule for the Correction of the Imbalance in the Vaginal Environment- Prospective, Multicentric, Two-arm, Randomized, Vehicle-controlled, Blinded, Comparative Clinical Trial
Randomized, blinded vehicle-controlled multicenter clinical trial (MAT072017) to determine the effect of vaginal ovules containing 2 mg of the tea extract Matuzalem on the subjective symptoms (5-point scale pruritus (itching), dolor (pain), rubor (redness), fluor (discharge), and fetor (odor)), and objective symptoms (pH, Nugent score) of bacterial vaginosis. An ovule containing only the vehicle (polyethylene glycol 3000 S) was used as a control. The study was blinded from the perspective of the subject, investigator, laboratory personnel and data analyst.
The objective was to determine whether vaginal ovule with tea extract once-daily for 5-7 days
improves symptoms of intermediate vaginal flora and prevents the development of bacterial
vaginosis.
Composite primary endpoint designed as a drop in the Nugent score, vaginal pH, or improvement
of subjective symptoms was compared between the active and vehicle (polyethylene-glycol) arm
after 7 days of application and following 7 days after the application.
Secondary outcome measures were (1) Correction of the vaginal environment (as previously
defined) 7 days after the completion of the prescribed 7-day regimen (day 14); (2) change in
each parameter separately; (3) change in individual subjective symptoms, (4) exploratory
analysis of the microbial environment at each subject visit.
The study was approved and supervised by the National authority and Ethics committee and
prospectively registered in the Czech national medical device trial registry RZPRO and the
European medical device trial registry EUDAMED.
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