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

NCT04171947 | Completed

• 1 other identifier: MAT072017
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 14

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.

Conditions

Vaginosis, Bacterial; Vaginal Flora Imbalance

Keywords

Tea; Polyphenols; Nugent score; Antioxidants; Vaginal pH; complementary medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (39)

• 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

• Change in the pH alone after treatment completion

  following 7 days of the ovule daily application

• Change in the Nugent score alone after treatment completion

  following 7 days of the ovule daily application

• Change in the subjective symptoms (questionnaire) after treatment completion

  following 7 days of the ovule daily application

• Change in the pH alone after 7 days since treatment completion

  7 days after the completion of the 7-day treatment

Study Arms (2)

Matuzalem

EXPERIMENTAL

Tea extract vaginal ovule daily for 7 consecutive days

Device: Matuzalem ovule

Vehicle

SHAM COMPARATOR

Polyethylene glycol vaginal ovule daily for 7 consecutive days

Device: Vehicle ovule

Interventions

Matuzalem ovule DEVICE

vaginal ovule with 2 mg tea extract

Matuzalem

Vehicle ovule DEVICE

polyethylene glycol vaginal ovule

Vehicle

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (14)

Centrum ambulantní gynekologie a primární péče, s.r.o.

Brno, Czech Republic, 60200, Czechia

Location

MUDr. Milan Kučera. s.r.o.

Kladno, Czech Republic, 27201, Czechia

Location

MUDr. Eva Novotná - FEMCARE s.r.o.

Odolena Voda, Czech Republic, 25070, Czechia

Location

OB/GYN Associates, s.r.o.

Prague, Czech Republic, 11000, Czechia

Location

MediStar s.r.o.

Prague, Czech Republic, 12000, Czechia

Location

MUDr. Michal Jelšík

Prague, Czech Republic, 12800, Czechia

Location

Gyn Por Ivf MUDr. Samer Asad s.r.o.

Prague, Czech Republic, 147000, Czechia

Location

Mediva s.r.o.

Prague, Czech Republic, 15500, Czechia

Location

GYNEKOLOGIE Studentský dům s.r.o.

Prague, Czech Republic, 16000, Czechia

Location

LEVRET s.r.o.

Prague, Czech Republic, 16000, Czechia

Location

T.B. Gyn s.r.o.

Prague, Czech Republic, 16100, Czechia

Location

Gynelav s.r.o.

Prague, Czech Republic, 16500, Czechia

Location

GYNEDAN s.r.o.

Prague, Czech Republic, Czechia

Location

MUDr.Tereza Šmrhová-Kovács

Tábor, Czech Republic, 39003, Czechia

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Tomáš Doležal, MD et PhD

  Value Outcomes Ltd.

  STUDY DIRECTOR

• Luboš Chadim, MVDr

  Matuzalem.com-cz, s.r.o.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: blinded from the perspective of the participant, investigator, laboratory analyst and data analyst
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: vehicle-controlled two-arm

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 21, 2019
• Study Start: December 4, 2017
• Primary Completion: May 9, 2018
• Study Completion: May 9, 2018
• Last Updated: November 21, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (14)