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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
274
vaginal ovule with 2 mg tea extract
polyethylene glycol vaginal ovule
Centrum ambulantní gynekologie a primární péče, s.r.o.
Brno, Czech Republic, Czechia
MUDr. Milan Kučera. s.r.o.
Kladno, Czech Republic, Czechia
MUDr. Eva Novotná - FEMCARE s.r.o.
Odolena Voda, Czech Republic, Czechia
OB/GYN Associates, s.r.o.
Prague, Czech Republic, Czechia
MediStar s.r.o.
Prague, Czech Republic, Czechia
MUDr. Michal Jelšík
Prague, Czech Republic, Czechia
Gyn Por Ivf MUDr. Samer Asad s.r.o.
Prague, Czech Republic, Czechia
Mediva s.r.o.
Prague, Czech Republic, Czechia
GYNEKOLOGIE Studentský dům s.r.o.
Prague, Czech Republic, Czechia
LEVRET s.r.o.
Prague, Czech Republic, Czechia
...and 4 more locations
Composite endpoint (vaginal pH, Nugent score, subjective symptoms via questionnaire) after treatment completion
Correction of the vaginal environment after 7 days of once-daily application of the ovule was defined as: a drop-in Nugent score to \< 4 and/or a drop in vaginal pH to \< 4.5, or a subjective improvement in at least 2 symptoms by at least 2 points on a 5-point scale in patients whose baseline pH was \< 4.5 and NS \< 4. Subjective symptoms: Pruritus, dolor, rubor, fluor and fetor reported by the patient on 5-point scale (0=no problem to 4=severe problem)
Time frame: following 7 days of the ovule daily application
Composite endpoint (vaginal pH, Nugent score, subjective symptoms via questionnaire) after 7 days since treatment completion
Correction of the vaginal environment after 7 days after treatment completion defined as: a drop-in NS to \< 4 and/or a drop in vaginal pH to \< 4.5, or a subjective improvement in at least 2 symptoms by at least 2 points on a 5-point scale in patients whose baseline pH was \< 4.5 and NS \< 4. Subjective symptoms: Pruritus, dolor, rubor, fluor and fetor reported by the patient on 5-point scale (0=no problem to 4=severe problem)
Time frame: 7 days after the completion of the 7-day treatment
Change in the pH alone after treatment completion
Correction of the pH measured via pH strips
Time frame: following 7 days of the ovule daily application
Change in the Nugent score alone after treatment completion
Nugent score determined under 1000x magnification
Time frame: following 7 days of the ovule daily application
Change in the subjective symptoms (questionnaire) after treatment completion
Pruritus, dolor, rubor, fluor and fetor reported by the patient on 5-point scale (0=no problem to 4=severe problem)
Time frame: following 7 days of the ovule daily application
Change in the pH alone after 7 days since treatment completion
Correction of the pH measured via pH strips
Time frame: 7 days after the completion of the 7-day treatment
Change in the Nugent score alone 7 days after treatment completion
Nugent score determined under 1000x magnification
Time frame: 7 days after the completion of the 7-day treatment
Change in the subjective symptoms (questionnaire) 7 days after treatment completion
Pruritus, dolor, rubor, fluor and fetor reported by the patient on 5-point scale (0=no problem to 4=severe problem)
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: squamous epithelial cells
Quantification of: squamous epithelial cells under 1000x magnification
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: squamous epithelial cells
Quantification of: squamous epithelial cells under 1000x magnification
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: clue cells
Quantification of clue cells under 1000x magnification
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: clue cells
Quantification of clue cells under 1000x magnification
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: mixed flora
Quantification of mixed flora under 1000x magnification
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: mixed flora
Quantification of mixed flora under 1000x magnification
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: yeast as pseudomycelia
Quantification of yeast as pseudomycelia under 1000x magnification
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: yeast as pseudomycelia
Quantification of yeast as pseudomycelia under 1000x magnification
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: Gram negative diplococci
Quantification of: Gram negative diplococci under 1000x magnification
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: Gram negative diplococci
Quantification of: Gram negative diplococci under 1000x magnification
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: fibrous Lactobacillus
Quantification of: fibrous Lactobacillus under 1000x magnification
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: fibrous Lactobacillus
Quantification of: fibrous Lactobacillus under 1000x magnification
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: Gardnerella
Quantification of: Gardnerella under 1000x magnification
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: Gardnerella
Quantification of: Gardnerella under 1000x magnification
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: spirochetes
Quantification of: spirochetes under 1000x magnification
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: spirochetes
Quantification of: spirochetes under 1000x magnification
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: parabasal epithelial cells
Quantification of: parabasal epithelial cells under 1000x magnification
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: parabasal epithelial cells
Quantification of: parabasal epithelial cells under 1000x magnification
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: leukocytes
Quantification of: leukocytes under 1000x magnification
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: leukocytes
Quantification of: leukocytes under 1000x magnification
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: yeast as blastospores
Quantification of: yeast as blastospores under 1000x magnification
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: yeast as blastospores
Quantification of: yeast as blastospores under 1000x magnification
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: Gram pos. cocci in chains
Quantification of: Gram pos. cocci in chains under 1000x magnification
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: Gram pos. cocci in chains
Quantification of: Gram pos. cocci in chains under 1000x magnification
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: Lactobacillus
Quantification of: Lactobacillus under 1000x magnification
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: Lactobacillus
Quantification of: Lactobacillus under 1000x magnification
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: Mobilincus
Quantification of: Mobilincus under 1000x magnification
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: Mobilincus
Quantification of: Mobilincus under 1000x magnification
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: Leptotrichia
Quantification of: Leptotrichia under 1000x magnification
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: Leptotrichia
Quantification of: Leptotrichia under 1000x magnification
Time frame: 7 days after the completion of the 7-day treatment
Exploratory analysis of the microbial environment after treatment completion: Trichomonas vaginalis
Quantification of: Trichomonas vaginalis under 1000 magnification
Time frame: following 7 days of the ovule daily application
Exploratory analysis of the microbial environment after 7 days after treatment completion: Trichomonas vaginalis
Quantification of: Trichomonas vaginalis under 1000 magnification
Time frame: 7 days after the completion of the 7-day treatment
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