Vaginal Ovule With Flavonoid Tea Extract for the Correction of Imbalance in the Vaginal Environment (NCT04171947) | Clinical Trial Compass
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 range
18 Years – 55 Years
Sex
FEMALE
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite endpoint (vaginal pH, Nugent score, subjective symptoms via questionnaire) after treatment completion
Timeframe: following 7 days of the ovule daily application