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Completed

NCT Number: NCT04171947

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

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.

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Key information

Conditions

Vaginosis, Bacterial Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Urogenital Diseases Vaginal Diseases Vaginal Flora Imbalance Vaginitis

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centrum ambulantní gynekologie a primární péče, s.r.o., Brno, Czech Republic, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Matuzalem ovule

Device

vaginal ovule with 2 mg tea extract

Vehicle ovule

Device

polyethylene glycol vaginal ovule

Primary outcomes

  1. Composite endpoint (vaginal pH, Nugent score, subjective symptoms via questionnaire) after treatment completion

    Time frame: following 7 days of the ovule daily application

    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)

Secondary outcomes

  1. Composite endpoint (vaginal pH, Nugent score, subjective symptoms via questionnaire) after 7 days since treatment completion

    Time frame: 7 days after the completion of the 7-day treatment

    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)

  2. Change in the pH alone after treatment completion

    Time frame: following 7 days of the ovule daily application

    Correction of the pH measured via pH strips

  3. Change in the Nugent score alone after treatment completion

    Time frame: following 7 days of the ovule daily application

    Nugent score determined under 1000x magnification

  4. Change in the subjective symptoms (questionnaire) after treatment completion

    Time frame: following 7 days of the ovule daily application

    Pruritus, dolor, rubor, fluor and fetor reported by the patient on 5-point scale (0=no problem to 4=severe problem)

  5. Change in the pH alone after 7 days since treatment completion

    Time frame: 7 days after the completion of the 7-day treatment

    Correction of the pH measured via pH strips

  6. Change in the Nugent score alone 7 days after treatment completion

    Time frame: 7 days after the completion of the 7-day treatment

    Nugent score determined under 1000x magnification

  7. Change in the subjective symptoms (questionnaire) 7 days after treatment completion

    Time frame: 7 days after the completion of the 7-day treatment

    Pruritus, dolor, rubor, fluor and fetor reported by the patient on 5-point scale (0=no problem to 4=severe problem)

  8. Exploratory analysis of the microbial environment after treatment completion: squamous epithelial cells

    Time frame: following 7 days of the ovule daily application

    Quantification of: squamous epithelial cells under 1000x magnification

  9. Exploratory analysis of the microbial environment after 7 days after treatment completion: squamous epithelial cells

    Time frame: 7 days after the completion of the 7-day treatment

    Quantification of: squamous epithelial cells under 1000x magnification

  10. Exploratory analysis of the microbial environment after treatment completion: clue cells

    Time frame: following 7 days of the ovule daily application

    Quantification of clue cells under 1000x magnification

  11. Exploratory analysis of the microbial environment after 7 days after treatment completion: clue cells

    Time frame: 7 days after the completion of the 7-day treatment

    Quantification of clue cells under 1000x magnification

  12. Exploratory analysis of the microbial environment after treatment completion: mixed flora

    Time frame: following 7 days of the ovule daily application

    Quantification of mixed flora under 1000x magnification

  13. Exploratory analysis of the microbial environment after 7 days after treatment completion: mixed flora

    Time frame: 7 days after the completion of the 7-day treatment

    Quantification of mixed flora under 1000x magnification

  14. Exploratory analysis of the microbial environment after treatment completion: yeast as pseudomycelia

    Time frame: following 7 days of the ovule daily application

    Quantification of yeast as pseudomycelia under 1000x magnification

  15. Exploratory analysis of the microbial environment after 7 days after treatment completion: yeast as pseudomycelia

    Time frame: 7 days after the completion of the 7-day treatment

    Quantification of yeast as pseudomycelia under 1000x magnification

  16. Exploratory analysis of the microbial environment after treatment completion: Gram negative diplococci

    Time frame: following 7 days of the ovule daily application

    Quantification of: Gram negative diplococci under 1000x magnification

  17. Exploratory analysis of the microbial environment after 7 days after treatment completion: Gram negative diplococci

    Time frame: 7 days after the completion of the 7-day treatment

    Quantification of: Gram negative diplococci under 1000x magnification

  18. Exploratory analysis of the microbial environment after treatment completion: fibrous Lactobacillus

    Time frame: following 7 days of the ovule daily application

    Quantification of: fibrous Lactobacillus under 1000x magnification

  19. Exploratory analysis of the microbial environment after 7 days after treatment completion: fibrous Lactobacillus

    Time frame: 7 days after the completion of the 7-day treatment

    Quantification of: fibrous Lactobacillus under 1000x magnification

  20. Exploratory analysis of the microbial environment after treatment completion: Gardnerella

    Time frame: following 7 days of the ovule daily application

    Quantification of: Gardnerella under 1000x magnification

  21. Exploratory analysis of the microbial environment after 7 days after treatment completion: Gardnerella

    Time frame: 7 days after the completion of the 7-day treatment

    Quantification of: Gardnerella under 1000x magnification

  22. Exploratory analysis of the microbial environment after treatment completion: spirochetes

    Time frame: following 7 days of the ovule daily application

    Quantification of: spirochetes under 1000x magnification

  23. Exploratory analysis of the microbial environment after 7 days after treatment completion: spirochetes

    Time frame: 7 days after the completion of the 7-day treatment

    Quantification of: spirochetes under 1000x magnification

  24. Exploratory analysis of the microbial environment after treatment completion: parabasal epithelial cells

    Time frame: following 7 days of the ovule daily application

    Quantification of: parabasal epithelial cells under 1000x magnification

  25. Exploratory analysis of the microbial environment after 7 days after treatment completion: parabasal epithelial cells

    Time frame: 7 days after the completion of the 7-day treatment

    Quantification of: parabasal epithelial cells under 1000x magnification

  26. Exploratory analysis of the microbial environment after treatment completion: leukocytes

    Time frame: following 7 days of the ovule daily application

    Quantification of: leukocytes under 1000x magnification

  27. Exploratory analysis of the microbial environment after 7 days after treatment completion: leukocytes

    Time frame: 7 days after the completion of the 7-day treatment

    Quantification of: leukocytes under 1000x magnification

  28. Exploratory analysis of the microbial environment after treatment completion: yeast as blastospores

    Time frame: following 7 days of the ovule daily application

    Quantification of: yeast as blastospores under 1000x magnification

  29. Exploratory analysis of the microbial environment after 7 days after treatment completion: yeast as blastospores

    Time frame: 7 days after the completion of the 7-day treatment

    Quantification of: yeast as blastospores under 1000x magnification

  30. Exploratory analysis of the microbial environment after treatment completion: Gram pos. cocci in chains

    Time frame: following 7 days of the ovule daily application

    Quantification of: Gram pos. cocci in chains under 1000x magnification

  31. Exploratory analysis of the microbial environment after 7 days after treatment completion: Gram pos. cocci in chains

    Time frame: 7 days after the completion of the 7-day treatment

    Quantification of: Gram pos. cocci in chains under 1000x magnification

  32. Exploratory analysis of the microbial environment after treatment completion: Lactobacillus

    Time frame: following 7 days of the ovule daily application

    Quantification of: Lactobacillus under 1000x magnification

  33. Exploratory analysis of the microbial environment after 7 days after treatment completion: Lactobacillus

    Time frame: 7 days after the completion of the 7-day treatment

    Quantification of: Lactobacillus under 1000x magnification

  34. Exploratory analysis of the microbial environment after treatment completion: Mobilincus

    Time frame: following 7 days of the ovule daily application

    Quantification of: Mobilincus under 1000x magnification

  35. Exploratory analysis of the microbial environment after 7 days after treatment completion: Mobilincus

    Time frame: 7 days after the completion of the 7-day treatment

    Quantification of: Mobilincus under 1000x magnification

  36. Exploratory analysis of the microbial environment after treatment completion: Leptotrichia

    Time frame: following 7 days of the ovule daily application

    Quantification of: Leptotrichia under 1000x magnification

  37. Exploratory analysis of the microbial environment after 7 days after treatment completion: Leptotrichia

    Time frame: 7 days after the completion of the 7-day treatment

    Quantification of: Leptotrichia under 1000x magnification

  38. Exploratory analysis of the microbial environment after treatment completion: Trichomonas vaginalis

    Time frame: following 7 days of the ovule daily application

    Quantification of: Trichomonas vaginalis under 1000 magnification

  39. Exploratory analysis of the microbial environment after 7 days after treatment completion: Trichomonas vaginalis

    Time frame: 7 days after the completion of the 7-day treatment

    Quantification of: Trichomonas vaginalis under 1000 magnification

Sponsors and collaborators

Lead sponsor

Value Outcomes Ltd.

Other

Collaborators

  • Matuzalem.com-cz, s.r.o.

Registry information

Official study 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

Acronym: MAT072017

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 21, 2019
Registry last updated
Nov 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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