Vaginal Ovule With Flavonoid Tea Extract for the Correction of Imbalance in the Vaginal Environment (MAT072017)

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.

Composite endpoint (vaginal pH, Nugent score, subjective symptoms via questionnaire) after treatment completion

Correction of the vaginal environment after 7 days of once-daily application of the ovule was defined as: a drop-in Nugent score to < 4 and/or a drop in vaginal pH to < 4.5, or a subjective improvement in at least 2 symptoms by at least 2 points on a 5-point scale in patients whose baseline pH was < 4.5 and NS < 4. Subjective symptoms: Pruritus, dolor, rubor, fluor and fetor reported by the patient on 5-point scale (0=no problem to 4=severe problem)

Composite endpoint (vaginal pH, Nugent score, subjective symptoms via questionnaire) after 7 days since treatment completion

Correction of the vaginal environment after 7 days after treatment completion defined as: a drop-in NS to < 4 and/or a drop in vaginal pH to < 4.5, or a subjective improvement in at least 2 symptoms by at least 2 points on a 5-point scale in patients whose baseline pH was < 4.5 and NS < 4. Subjective symptoms: Pruritus, dolor, rubor, fluor and fetor reported by the patient on 5-point scale (0=no problem to 4=severe problem)

Pruritus, dolor, rubor, fluor and fetor reported by the patient on 5-point scale (0=no problem to 4=severe problem)

Pruritus, dolor, rubor, fluor and fetor reported by the patient on 5-point scale (0=no problem to 4=severe problem)

Exploratory analysis of the microbial environment after treatment completion: squamous epithelial cells

Exploratory analysis of the microbial environment after 7 days after treatment completion: squamous epithelial cells

Exploratory analysis of the microbial environment after 7 days after treatment completion: clue cells

Exploratory analysis of the microbial environment after 7 days after treatment completion: mixed flora

Exploratory analysis of the microbial environment after 7 days after treatment completion: yeast as pseudomycelia

Exploratory analysis of the microbial environment after treatment completion: Gram negative diplococci

Exploratory analysis of the microbial environment after 7 days after treatment completion: Gram negative diplococci

Exploratory analysis of the microbial environment after 7 days after treatment completion: fibrous Lactobacillus

Exploratory analysis of the microbial environment after 7 days after treatment completion: Gardnerella

Exploratory analysis of the microbial environment after 7 days after treatment completion: spirochetes

Exploratory analysis of the microbial environment after treatment completion: parabasal epithelial cells

Exploratory analysis of the microbial environment after 7 days after treatment completion: parabasal epithelial cells

Exploratory analysis of the microbial environment after 7 days after treatment completion: leukocytes

Exploratory analysis of the microbial environment after 7 days after treatment completion: yeast as blastospores

Exploratory analysis of the microbial environment after treatment completion: Gram pos. cocci in chains

Exploratory analysis of the microbial environment after 7 days after treatment completion: Gram pos. cocci in chains

Exploratory analysis of the microbial environment after 7 days after treatment completion: Lactobacillus

Exploratory analysis of the microbial environment after 7 days after treatment completion: Mobilincus

Exploratory analysis of the microbial environment after 7 days after treatment completion: Leptotrichia

Exploratory analysis of the microbial environment after 7 days after treatment completion: Trichomonas vaginalis

Inclusion Criteria: premenopausal participants disturbed vaginal environment not in need of antibiotic or antimycotic treatment participants were citizens of the Czech Republic age between 18 and 55 years either a vaginal pH > 4.5 or/and vaginal discomfort able to follow the prescribed regimen informed consents prior to any intervention, including diagnostic procedures. Exclusion Criteria: no vaginal bleeding of unknown aetiology hypersensitivity pregnancy lactation period during enrollment antibiotics in the previous 30 days treated with any products with similar indication acute urogenital infection diabetes mellitus advanced oncologic disease participant to other trial Nugent score above 6