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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Vaginitis, Bacterial Vaginosis

Intervention / Treatment
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* Device: Cerviron®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cerviron®|Cerviron® is a medical device manufactured by PFC Pharma Manufacturing SL formulated following the provisions of the European Regulation 2017/745 on Medical Devices. Cerviron® is an invasive medical device of short-term use classified under annex VIII of the European Regulation 2017/745 as class IIb according to Rule 21. Cerviron® has a complex composition consisting of three topical pharmaceutical products - hexylresorcinol, collagen and bismuth subgallate - and four phytotherapeutic extracts - Calendula officinalis, Hydrastis canadensis, Thymus vulgaris extract and Curcuma longa. The Instructions for use specify its field of use as adjuvant in the treatment of acute and chronic vulvovaginitis of mechanical etiology, caused by changes of vaginal pH and changes of the vaginal flora and of cervical lesions of mechanical origin.|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vulvovaginitis, vaginal discharge, vaginal pH