NCT04171947

Vaginal Ovule With Flavonoid Tea Extract for the Correction of Imbalance in the Vaginal Environment

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 274 (actual)
• Sponsor: Value Outcomes Ltd. · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Vaginosis, Bacterial
• Vaginal Flora Imbalance

Interventions

Type	Name	Description
DEVICE	Matuzalem ovule	vaginal ovule with 2 mg tea extract
DEVICE	Vehicle ovule	polyethylene glycol vaginal ovule

Timeline

• Start date: 2017-12-04
• Primary completion: 2018-05-09
• Completion: 2018-05-09
• First posted: 2019-11-21
• Last updated: 2019-11-21

Locations

14 sites across 1 country: Czechia