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

NCT04171947 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2019-11-21

No results posted yet for this study

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

Interventions

DEVICE

Matuzalem ovule

vaginal ovule with 2 mg tea extract

DEVICE

Vehicle ovule

polyethylene glycol vaginal ovule

Sponsors & Collaborators

  • Matuzalem.com-cz, s.r.o.

    collaborator UNKNOWN

  • Value Outcomes Ltd.

    lead OTHER

Principal Investigators

  • Tomáš Doležal, MD et PhD · Value Outcomes Ltd.

  • Luboš Chadim, MVDr · Matuzalem.com-cz, s.r.o.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-04
Primary Completion
2018-05-09
Completion
2018-05-09

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04171947 on ClinicalTrials.gov