Clinical trial NCT04171947: Vaginal Ovule With Flavonoid Tea Extract for the Correction of Imbalance in the Vaginal Environment
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginosis, Bacterial
Vaginal Flora Imbalance
Keywords: Tea
Polyphenols
Nugent score
Antioxidants
Vaginal pH
complementary medicine
Lead sponsor: Value Outcomes Ltd.
Sponsor class: OTHER
Collaborators: name: Matuzalem.com-cz, s.r.o.
First posted: 2019-11-21
Enrollment: 274
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: vehicle-controlled two-arm
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite endpoint (vaginal pH, Nugent score, subjective symptoms via questionnaire) after treatment completion
timeFrame: following 7 days of the ovule daily application
Secondary outcomes:
measure: Composite endpoint (vaginal pH, Nugent score, subjective symptoms via questionnaire) after 7 days since treatment completion
timeFrame: 7 days after the completion of the 7-day treatment
measure: Change in the pH alone after treatment completion
timeFrame: following 7 days of the ovule daily application
measure: Change in the Nugent score alone after treatment completion
timeFrame: following 7 days of the ovule daily application
measure: Change in the subjective symptoms (questionnaire) after treatment completion
timeFrame: following 7 days of the ovule daily application
measure: Change in the pH alone after 7 days since treatment completion
timeFrame: 7 days after the completion of the 7-day treatment
measure: Change in the Nugent score alone 7 days after treatment completion
timeFrame: 7 days after the completion of the 7-day treatment
measure: Change in the subjective symptoms (questionnaire) 7 days after treatment completion
timeFrame: 7 days after the completion of the 7-day treatment
measure: Exploratory analysis of the microbial environment after treatment completion: squamous epithelial cells
timeFrame: following 7 days of the ovule daily application
measure: Exploratory analysis of the microbial environment after 7 days after treatment completion: squamous epithelial cells
timeFrame: 7 days after the completion of the 7-day treatment
measure: Exploratory analysis of the microbial environment after treatment completion: clue cells
timeFrame: following 7 days of the ovule daily application
measure: Exploratory analysis of the microbial environment after 7 days after treatment completion: clue cells
timeFrame: 7 days after the completion of the 7-day treatment
measure: Exploratory analysis of the microbial environment after treatment completion: mixed flora
timeFrame: following 7 days of the ovule daily application
measure: Exploratory analysis of the microbial environment after 7 days after treatment completion: mixed flora
timeFrame: 7 days after the completion of the 7-day treatment
measure: Exploratory analysis of the microbial environment after treatment completion: yeast as pseudomycelia
timeFrame: following 7 days of the ovule daily application
measure: Exploratory analysis of the microbial environment after 7 days after treatment completion: yeast as pseudomycelia
timeFrame: 7 days after the completion of the 7-day treatment
measure: Exploratory analysis of the microbial environment after treatment completion: Gram negative diplococci
timeFrame: following 7 days of the ovule daily application
measure: Exploratory analysis of the microbial environment after 7 days after treatment completion: Gram negative diplococci
timeFrame: 7 days after the completion of the 7-day treatment
measure: Exploratory analysis of the microbial environment after treatment completion: fibrous Lactobacillus
timeFrame: following 7 days of the ovule daily application
measure: Exploratory analysis of the microbial environment after 7 days after treatment completion: fibrous Lactobacillus
timeFrame: 7 days after the completion of the 7-day treatment
measure: Exploratory analysis of the microbial environment after treatment completion: Gardnerella
timeFrame: following 7 days of the ovule daily application
measure: Exploratory analysis of the microbial environment after 7 days after treatment completion: Gardnerella
timeFrame: 7 days after the completion of the 7-day treatment
measure: Exploratory analysis of the microbial environment after treatment completion: spirochetes
timeFrame: following 7 days of the ovule daily application
measure: Exploratory analysis of the microbial environment after 7 days after treatment completion: spirochetes
timeFrame: 7 days after the completion of the 7-day treatment
measure: Exploratory analysis of the microbial environment after treatment completion: parabasal epithelial cells
timeFrame: following 7 days of the ovule daily application
measure: Exploratory analysis of the microbial environment after 7 days after treatment completion: parabasal epithelial cells
timeFrame: 7 days after the completion of the 7-day treatment
measure: Exploratory analysis of the microbial environment after treatment completion: leukocytes
timeFrame: following 7 days of the ovule daily application
measure: Exploratory analysis of the microbial environment after 7 days after treatment completion: leukocytes
timeFrame: 7 days after the completion of the 7-day treatment
measure: Exploratory analysis of the microbial environment after treatment completion: yeast as blastospores
timeFrame: following 7 days of the ovule daily application
measure: Exploratory analysis of the microbial environment after 7 days after treatment completion: yeast as blastospores
timeFrame: 7 days after the completion of the 7-day treatment
measure: Exploratory analysis of the microbial environment after treatment completion: Gram pos. cocci in chains
timeFrame: following 7 days of the ovule daily application
measure: Exploratory analysis of the microbial environment after 7 days after treatment completion: Gram pos. cocci in chains
timeFrame: 7 days after the completion of the 7-day treatment
measure: Exploratory analysis of the microbial environment after treatment completion: Lactobacillus
timeFrame: following 7 days of the ovule daily application
measure: Exploratory analysis of the microbial environment after 7 days after treatment completion: Lactobacillus
timeFrame: 7 days after the completion of the 7-day treatment
measure: Exploratory analysis of the microbial environment after treatment completion: Mobilincus
timeFrame: following 7 days of the ovule daily application
measure: Exploratory analysis of the microbial environment after 7 days after treatment completion: Mobilincus
timeFrame: 7 days after the completion of the 7-day treatment
measure: Exploratory analysis of the microbial environment after treatment completion: Leptotrichia
timeFrame: following 7 days of the ovule daily application
measure: Exploratory analysis of the microbial environment after 7 days after treatment completion: Leptotrichia
timeFrame: 7 days after the completion of the 7-day treatment
measure: Exploratory analysis of the microbial environment after treatment completion: Trichomonas vaginalis
timeFrame: following 7 days of the ovule daily application
measure: Exploratory analysis of the microbial environment after 7 days after treatment completion: Trichomonas vaginalis
timeFrame: 7 days after the completion of the 7-day treatment
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Centrum ambulantní gynekologie a primární péče, s.r.o.
state: Czech Republic
city: Kladno
country: Czechia
facility: MUDr. Milan Kučera. s.r.o.
state: Czech Republic
city: Odolena Voda
country: Czechia
facility: MUDr. Eva Novotná - FEMCARE s.r.o.
state: Czech Republic
city: Prague
country: Czechia
facility: OB/GYN Associates, s.r.o.
state: Czech Republic
city: Prague
country: Czechia
facility: MediStar s.r.o.
state: Czech Republic
city: Prague
country: Czechia
facility: MUDr. Michal Jelšík
state: Czech Republic
city: Prague
country: Czechia
facility: Gyn Por Ivf MUDr. Samer Asad s.r.o.
state: Czech Republic
city: Prague
country: Czechia
facility: Mediva s.r.o.
state: Czech Republic
city: Prague
country: Czechia
facility: GYNEKOLOGIE Studentský dům s.r.o.
state: Czech Republic
city: Prague
country: Czechia
facility: LEVRET s.r.o.
state: Czech Republic
city: Prague
country: Czechia
facility: T.B. Gyn s.r.o.
state: Czech Republic
city: Prague
country: Czechia
facility: Gynelav s.r.o.
state: Czech Republic
city: Prague
country: Czechia
facility: GYNEDAN s.r.o.
state: Czech Republic
city: Tábor
country: Czechia
facility: MUDr.Tereza Šmrhová-Kovács
state: Czech Republic
Study officials:
affiliation: Value Outcomes Ltd.
name: Tomáš Doležal, MD et PhD
role: STUDY_DIRECTOR
affiliation: Matuzalem.com-cz, s.r.o.
name: Luboš Chadim, MVDr
role: STUDY_CHAIR
References: