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

Vaginosis, Bacterial Clinical Trial

— MAT072017  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04171947
• Other study ID #: MAT072017
• Status: Completed
• Phase: N/A
• Start date: December 4, 2017
• Est. completion date: May 9, 2018

Study information

• Verified date: November 2019
• Source: Value Outcomes Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: May 9, 2018
• Est. primary completion date: May 9, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Vaginal Flora Imbalance
• Vaginosis, Bacterial

Intervention

Device:
• Matuzalem ovule
vaginal ovule with 2 mg tea extract
• Vehicle ovule
polyethylene glycol vaginal ovule

Locations

Country	Name	City	State
Czechia	Centrum ambulantní gynekologie a primární péce, s.r.o.	Brno	Czech Republic
Czechia	MUDr. Milan Kucera. s.r.o.	Kladno	Czech Republic
Czechia	MUDr. Eva Novotná - FEMCARE s.r.o.	Odolena Voda	Czech Republic
Czechia	Gyn Por Ivf MUDr. Samer Asad s.r.o.	Prague	Czech Republic
Czechia	GYNEDAN s.r.o.	Prague	Czech Republic
Czechia	GYNEKOLOGIE Studentský dum s.r.o.	Prague	Czech Republic
Czechia	Gynelav s.r.o.	Prague	Czech Republic
Czechia	LEVRET s.r.o.	Prague	Czech Republic
Czechia	MediStar s.r.o.	Prague	Czech Republic
Czechia	Mediva s.r.o.	Prague	Czech Republic
Czechia	MUDr. Michal Jelšík	Prague	Czech Republic
Czechia	OB/GYN Associates, s.r.o.	Prague	Czech Republic
Czechia	T.B. Gyn s.r.o.	Prague	Czech Republic
Czechia	MUDr.Tereza Šmrhová-Kovács	Tábor	Czech Republic

Sponsors (2)

Lead Sponsor	Collaborator
Value Outcomes Ltd.	Matuzalem.com-cz, s.r.o.

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	following 7 days of the ovule daily application
Secondary	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)	7 days after the completion of the 7-day treatment
Secondary	Change in the pH alone after treatment completion	Correction of the pH measured via pH strips	following 7 days of the ovule daily application
Secondary	Change in the Nugent score alone after treatment completion	Nugent score determined under 1000x magnification	following 7 days of the ovule daily application
Secondary	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)	following 7 days of the ovule daily application
Secondary	Change in the pH alone after 7 days since treatment completion	Correction of the pH measured via pH strips	7 days after the completion of the 7-day treatment
Secondary	Change in the Nugent score alone 7 days after treatment completion	Nugent score determined under 1000x magnification	7 days after the completion of the 7-day treatment
Secondary	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)	7 days after the completion of the 7-day treatment
Secondary	Exploratory analysis of the microbial environment after treatment completion: squamous epithelial cells	Quantification of: squamous epithelial cells under 1000x magnification	following 7 days of the ovule daily application
Secondary	Exploratory analysis of the microbial environment after 7 days after treatment completion: squamous epithelial cells	Quantification of: squamous epithelial cells under 1000x magnification	7 days after the completion of the 7-day treatment
Secondary	Exploratory analysis of the microbial environment after treatment completion: clue cells	Quantification of clue cells under 1000x magnification	following 7 days of the ovule daily application
Secondary	Exploratory analysis of the microbial environment after 7 days after treatment completion: clue cells	Quantification of clue cells under 1000x magnification	7 days after the completion of the 7-day treatment
Secondary	Exploratory analysis of the microbial environment after treatment completion: mixed flora	Quantification of mixed flora under 1000x magnification	following 7 days of the ovule daily application
Secondary	Exploratory analysis of the microbial environment after 7 days after treatment completion: mixed flora	Quantification of mixed flora under 1000x magnification	7 days after the completion of the 7-day treatment
Secondary	Exploratory analysis of the microbial environment after treatment completion: yeast as pseudomycelia	Quantification of yeast as pseudomycelia under 1000x magnification	following 7 days of the ovule daily application
Secondary	Exploratory analysis of the microbial environment after 7 days after treatment completion: yeast as pseudomycelia	Quantification of yeast as pseudomycelia under 1000x magnification	7 days after the completion of the 7-day treatment
Secondary	Exploratory analysis of the microbial environment after treatment completion: Gram negative diplococci	Quantification of: Gram negative diplococci under 1000x magnification	following 7 days of the ovule daily application
Secondary	Exploratory analysis of the microbial environment after 7 days after treatment completion: Gram negative diplococci	Quantification of: Gram negative diplococci under 1000x magnification	7 days after the completion of the 7-day treatment
Secondary	Exploratory analysis of the microbial environment after treatment completion: fibrous Lactobacillus	Quantification of: fibrous Lactobacillus under 1000x magnification	following 7 days of the ovule daily application
Secondary	Exploratory analysis of the microbial environment after 7 days after treatment completion: fibrous Lactobacillus	Quantification of: fibrous Lactobacillus under 1000x magnification	7 days after the completion of the 7-day treatment
Secondary	Exploratory analysis of the microbial environment after treatment completion: Gardnerella	Quantification of: Gardnerella under 1000x magnification	following 7 days of the ovule daily application
Secondary	Exploratory analysis of the microbial environment after 7 days after treatment completion: Gardnerella	Quantification of: Gardnerella under 1000x magnification	7 days after the completion of the 7-day treatment
Secondary	Exploratory analysis of the microbial environment after treatment completion: spirochetes	Quantification of: spirochetes under 1000x magnification	following 7 days of the ovule daily application
Secondary	Exploratory analysis of the microbial environment after 7 days after treatment completion: spirochetes	Quantification of: spirochetes under 1000x magnification	7 days after the completion of the 7-day treatment
Secondary	Exploratory analysis of the microbial environment after treatment completion: parabasal epithelial cells	Quantification of: parabasal epithelial cells under 1000x magnification	following 7 days of the ovule daily application
Secondary	Exploratory analysis of the microbial environment after 7 days after treatment completion: parabasal epithelial cells	Quantification of: parabasal epithelial cells under 1000x magnification	7 days after the completion of the 7-day treatment
Secondary	Exploratory analysis of the microbial environment after treatment completion: leukocytes	Quantification of: leukocytes under 1000x magnification	following 7 days of the ovule daily application
Secondary	Exploratory analysis of the microbial environment after 7 days after treatment completion: leukocytes	Quantification of: leukocytes under 1000x magnification	7 days after the completion of the 7-day treatment
Secondary	Exploratory analysis of the microbial environment after treatment completion: yeast as blastospores	Quantification of: yeast as blastospores under 1000x magnification	following 7 days of the ovule daily application
Secondary	Exploratory analysis of the microbial environment after 7 days after treatment completion: yeast as blastospores	Quantification of: yeast as blastospores under 1000x magnification	7 days after the completion of the 7-day treatment
Secondary	Exploratory analysis of the microbial environment after treatment completion: Gram pos. cocci in chains	Quantification of: Gram pos. cocci in chains under 1000x magnification	following 7 days of the ovule daily application
Secondary	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	7 days after the completion of the 7-day treatment
Secondary	Exploratory analysis of the microbial environment after treatment completion: Lactobacillus	Quantification of: Lactobacillus under 1000x magnification	following 7 days of the ovule daily application
Secondary	Exploratory analysis of the microbial environment after 7 days after treatment completion: Lactobacillus	Quantification of: Lactobacillus under 1000x magnification	7 days after the completion of the 7-day treatment
Secondary	Exploratory analysis of the microbial environment after treatment completion: Mobilincus	Quantification of: Mobilincus under 1000x magnification	following 7 days of the ovule daily application
Secondary	Exploratory analysis of the microbial environment after 7 days after treatment completion: Mobilincus	Quantification of: Mobilincus under 1000x magnification	7 days after the completion of the 7-day treatment
Secondary	Exploratory analysis of the microbial environment after treatment completion: Leptotrichia	Quantification of: Leptotrichia under 1000x magnification	following 7 days of the ovule daily application
Secondary	Exploratory analysis of the microbial environment after 7 days after treatment completion: Leptotrichia	Quantification of: Leptotrichia under 1000x magnification	7 days after the completion of the 7-day treatment
Secondary	Exploratory analysis of the microbial environment after treatment completion: Trichomonas vaginalis	Quantification of: Trichomonas vaginalis under 1000 magnification	following 7 days of the ovule daily application
Secondary	Exploratory analysis of the microbial environment after 7 days after treatment completion: Trichomonas vaginalis	Quantification of: Trichomonas vaginalis under 1000 magnification	7 days after the completion of the 7-day treatment