MAT072017: Vaginal Ovule With Flavonoid Tea Extract for the Correction of Imbalance in the Vaginal Environment

• Sponsor: Value Outcomes Ltd. (Other)
• Overall Status: Completed
• CT.gov ID: NCT04171947
• Collaborator: Matuzalem.com-cz, s.r.o. (Other)
• Enrollment: 274
• Locations: 14
• Arms: 2
• Actual Duration (Months): 5.1
• Patients Per Site: 19.6
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vaginosis, Bacterial; Vaginal Flora Imbalance	Device: Matuzalem ovule; Device: Vehicle ovule	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 274 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: vehicle-controlled two-armvehicle-controlled two-arm
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: blinded from the perspective of the participant, investigator, laboratory analyst and data analyst
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Dec 4, 2017
• Actual Primary Completion Date: May 9, 2018
• Actual Study Completion Date: May 9, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Matuzalem Tea extract vaginal ovule daily for 7 consecutive days	Device: Matuzalem ovule; vaginal ovule with 2 mg tea extract
Sham Comparator: Vehicle Polyethylene glycol vaginal ovule daily for 7 consecutive days	Device: Vehicle ovule; polyethylene glycol vaginal ovule

Outcome Measures

Primary Outcome Measures

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

1. Composite endpoint (vaginal pH, Nugent score, subjective symptoms via questionnaire) after 7 days since treatment completion [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 [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 [following 7 days of the ovule daily application]

   Nugent score determined under 1000x magnification

4. Change in the subjective symptoms (questionnaire) after treatment completion [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [7 days after the completion of the 7-day treatment]

    Quantification of: Trichomonas vaginalis under 1000 magnification

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centrum ambulantní gynekologie a primární péče, s.r.o.	Brno	Czech Republic	Czechia	60200
2	MUDr. Milan Kučera. s.r.o.	Kladno	Czech Republic	Czechia	27201
3	MUDr. Eva Novotná - FEMCARE s.r.o.	Odolena Voda	Czech Republic	Czechia	25070
4	OB/GYN Associates, s.r.o.	Prague	Czech Republic	Czechia	11000
5	MediStar s.r.o.	Prague	Czech Republic	Czechia	12000
6	MUDr. Michal Jelšík	Prague	Czech Republic	Czechia	12800
7	Gyn Por Ivf MUDr. Samer Asad s.r.o.	Prague	Czech Republic	Czechia	147000
8	Mediva s.r.o.	Prague	Czech Republic	Czechia	15500
9	GYNEKOLOGIE Studentský dům s.r.o.	Prague	Czech Republic	Czechia	16000
10	LEVRET s.r.o.	Prague	Czech Republic	Czechia	16000
11	T.B. Gyn s.r.o.	Prague	Czech Republic	Czechia	16100
12	Gynelav s.r.o.	Prague	Czech Republic	Czechia	16500
13	GYNEDAN s.r.o.	Prague	Czech Republic	Czechia
14	MUDr.Tereza Šmrhová-Kovács	Tábor	Czech Republic	Czechia	39003

Sponsors and Collaborators

• Value Outcomes Ltd.
• Matuzalem.com-cz, s.r.o.

Investigators

• Study Director: Tomáš Doležal, MD et PhD, Value Outcomes Ltd.
• Study Chair: Luboš Chadim, MVDr, Matuzalem.com-cz, s.r.o.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Value Outcomes Ltd.
• ClinicalTrials.gov Identifier: NCT04171947
• Other Study ID Numbers: MAT072017
• First Posted: Nov 21, 2019
• Last Update Posted: Nov 21, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Value Outcomes Ltd.: Tea; Polyphenols; Nugent score; Antioxidants; Vaginal pH; complementary medicine
• Additional relevant MeSH terms: Vaginosis, Bacterial

Study Results

No Results Posted as of Nov 21, 2019