Real-world Performance and Safety of Cerviron® in the Treatment of Vaginitis

April 18, 2023 updated by: Perfect Care Distribution

Real-world Performance and Safety of Cerviron® Medical Device in the Treatment of Various Types of Vaginitis

Vaginitis is a broad term that includes a range of gynecological disorders characterized by infection of vaginal mucosa, inflammation of vulva and alteration of the normal vaginal microflora. The most prevalent is bacterial vaginosis, followed by other clinical entities such as candidiasis, trichomoniasis and non-specific vaginitis.

A collection of clinical data was conducted to assess the tolerability of Cerviron® ovules in the treatment and management of various types of vaginitis in clinical practice. A total of 111 women aged between 20 and 70 years were recruited, 71 of whom were treated with Cerviron® ovules as monotherapy and 40 who used Cerviron® ovules as supportive treatment in conjunction with antibiotic therapy. The aim of our study was to assess the relief in vaginal symptoms and changes in the normal vaginal pH level after 3 months of treatment with Cerviron® medical device in real-life clinical practice settings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was designed as real-world evidence study with the primary purpose to assess the performance and tolerance of Cerviron® ovules in the treatment and management of various types of vulvovaginitis. The study collected clinical data from 28 different specialized gynecology clinical facilities. The study was conducted between May 20, 2021 and August 31, 2021.

The primary objective of this study was to assess the tolerability of Cerviron® ovules in the treatment and management of various types of vulvovaginitis, but also to confirm its performance both on symptoms relief and as a user-friendly device. The secondary objective of this study was to assess the performance of the medical device by clinical exam and patients' degree of satisfaction. The study design consisted of 3 or 4 visits over 90 ± 3 days. Cerviron® ovules were applied intravaginally, once per day, on the first day after menstruation and for 15 days during 3 consecutive months.

Data of 111 women aged between 20 and 70 years were analyzed, 71 of whom were treated with Cerviron® ovules as monotherapy and 40 who used Cerviron® ovules as supportive treatment in conjunction with anti-infectious therapy.

The symptoms recorded in the medical charts were followed to determine the performance of the medical device during the treatment.

Study Type

Observational

Enrollment (Actual)

111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucharest, Romania
        • Spitalul Clinic Dr. Ion Cantacuzino Bucharest
      • Cluj-Napoca, Romania
        • Med Life Humanitas Cluj-Napoca
      • Craiova, Romania
        • Cabinet Medical - Dr. Saleh K. Majed
      • Iaşi, Romania
        • Cabinet Medical - Dr. Surpanelu Oana
      • Piteşti, Romania
        • Clinica Natisan Pitesti
      • Râmnicu Vâlcea, Romania
        • Cabinet Dr. Rădulescu G. Mihaela Elena
      • Sibiu, Romania
        • Pan Medical Sibiu
      • Timişoara, Romania
        • Clinica Medicala Dr. Cioata Ionel Trifon
      • Tulcea, Romania
        • Spitalul Judetean de Urgenta Tulcea
      • Târgu Jiu, Romania
        • Cabinet Dr. Ioana Trotea Targu Jiu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Women aged between 20 and 70 years were treated with Cerviron® ovules as monotherapy and Cerviron® ovules as supportive treatment in conjunction with the antibiotic therapy having specific symptoms such as leukorrhea, vaginal itching, pain and a feeling of tension, vaginal burning, erythema, abnormal odor of vaginal secretions, dysuria and dyspareunia.

Description

Inclusion Criteria:

  • Adult females with a diagnosis of infectious or non-infectious vaginitis and treated with Cerviron® with or without anti-infectious treatment for at least three months:
  • Negative result for Gardnerella vaginalis, Candida albicans, Trichomonas vaginalis.

Exclusion Criteria:

  • Subjects with diagnosed abnormal genital bleeding;
  • Subject with vulvar, vaginal or cervical cancer;
  • Subjects with other inflammatory gynecological conditions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of the medical device
Time Frame: 3 months
the number of possible adverse Number of reactions observed during the treatment
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in the vaginal discharge aspect
Time Frame: 3 months
Presence/absence of abnormal/normal vaginal discharge
3 months
Improvement in the association of vaginal symptoms (burn and pain)
Time Frame: 3 months
Presence/absence of vaginal symptoms (burn and pain)
3 months
Improvement in vaginal irritation
Time Frame: 3 months
Presence/absence of vaginal irritation
3 months
Measurement of vaginal pH
Time Frame: 3 months
Normalization of vaginal pH values
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Perfect Care Distribution

Collaborators

MDX Research

Investigators

  • Study Director: Ema Peta, Perfect Care Distribution

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2021

Primary Completion (Actual)

March 20, 2022

Study Completion (Actual)

May 30, 2022

Study Registration Dates

First Submitted

November 18, 2022

First Submitted That Met QC Criteria

December 7, 2022

First Posted (Actual)

December 15, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYRONRW/01/2022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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