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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

274 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-04

Study Completion Date

2018-05-09

Brief Summary

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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.

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Detailed Description

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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

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Vaginosis, Bacterial Vaginal Flora Imbalance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

vehicle-controlled two-arm

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

blinded from the perspective of the participant, investigator, laboratory analyst and data analyst

Study Groups

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Matuzalem

Tea extract vaginal ovule daily for 7 consecutive days

Group Type EXPERIMENTAL

Matuzalem ovule

Intervention Type DEVICE

vaginal ovule with 2 mg tea extract

Vehicle

Polyethylene glycol vaginal ovule daily for 7 consecutive days

Group Type SHAM_COMPARATOR

Vehicle ovule

Intervention Type DEVICE

polyethylene glycol vaginal ovule

Interventions

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Matuzalem ovule

vaginal ovule with 2 mg tea extract

Intervention Type DEVICE

Vehicle ovule

polyethylene glycol vaginal ovule

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tomáš Doležal, MD et PhD

Role: STUDY_DIRECTOR

Value Outcomes Ltd.

Luboš Chadim, MVDr

Role: STUDY_CHAIR

Matuzalem.com-cz, s.r.o.

Locations

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Centrum ambulantní gynekologie a primární péče, s.r.o.

Brno, Czech Republic, Czechia

Site Status

MUDr. Milan Kučera. s.r.o.

Kladno, Czech Republic, Czechia

Site Status