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

Value Outcomes

Status: Completed

Conditions: Vaginosis, Bacterial; Vaginal Flora Imbalance

Treatments: Device: Vehicle ovule; Device: Matuzalem ovule

Study type: Interventional

Funder types: Other

Identifiers

NCT04171947

MAT072017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 274 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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274 participants in 2 patient groups

Matuzalem

Experimental group

Description:

Tea extract vaginal ovule daily for 7 consecutive days

Treatment:

Device: Matuzalem ovule

Vehicle

Sham Comparator group

Description:

Polyethylene glycol vaginal ovule daily for 7 consecutive days

Treatment:

Device: Vehicle ovule