CompletedNot Applicable

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

Czechia274 participantsStarted 2017-12-04

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: following 7 days of the ovule daily application

Trial details

NCT IDNCT04171947

SponsorValue Outcomes Ltd.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-05-09