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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04171947
Other study ID # MAT072017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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