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

Sponsor

Perfect Care Distribution (Industry)

Overall Status

Completed

CT.gov ID

NCT05652959

Collaborator

MDX Research (Other)

111

Enrollment

Locations

12.3

Actual Duration (Months)

11.1

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Vaginitis Bacterial Vaginosis	Device: Cerviron®

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 Design

Study Type:

Observational

Actual Enrollment :

111 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 20, 2021

Actual Primary Completion Date :

Mar 20, 2022

Actual Study Completion Date :

May 30, 2022

Outcome Measures

Primary Outcome Measures

Safety of the medical device [3 months]
the number of possible adverse Number of reactions observed during the treatment

Secondary Outcome Measures

Improvement in the vaginal discharge aspect [3 months]
Presence/absence of abnormal/normal vaginal discharge
Improvement in the association of vaginal symptoms (burn and pain) [3 months]
Presence/absence of vaginal symptoms (burn and pain)
Improvement in vaginal irritation [3 months]
Presence/absence of vaginal irritation
Measurement of vaginal pH [3 months]
Normalization of vaginal pH values

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

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.

Contacts and Locations

Locations

	Site	City	Country
1	Spitalul Clinic Dr. Ion Cantacuzino Bucharest	Bucharest	Romania
2	Med Life Humanitas Cluj-Napoca	Cluj-Napoca	Romania
3	Cabinet Medical - Dr. Saleh K. Majed	Craiova	Romania
4	Cabinet Medical - Dr. Surpanelu Oana	Iaşi	Romania
5	Clinica Natisan Pitesti	Piteşti	Romania
6	Cabinet Dr. Rădulescu G. Mihaela Elena	Râmnicu Vâlcea	Romania
7	Pan Medical Sibiu	Sibiu	Romania
8	Clinica Medicala Dr. Cioata Ionel Trifon	Timişoara	Romania
9	Spitalul Judetean de Urgenta Tulcea	Tulcea	Romania
10	Cabinet Dr. Ioana Trotea Targu Jiu	Târgu Jiu	Romania