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

Bacterial Vaginosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05652959
• Other study ID #: CYRONRW/01/2022
• Status: Completed
• Start date: May 20, 2021
• Est. completion date: May 30, 2022

Study information

• Verified date: April 2023
• Source: Perfect Care Distribution
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: May 30, 2022
• Est. primary completion date: March 20, 2022
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginitis
• Vaginosis, Bacterial

Intervention

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.

Locations

Country	Name	City	State
Romania	Spitalul Clinic Dr. Ion Cantacuzino Bucharest	Bucharest
Romania	Med Life Humanitas Cluj-Napoca	Cluj-Napoca
Romania	Cabinet Medical - Dr. Saleh K. Majed	Craiova
Romania	Cabinet Medical - Dr. Surpanelu Oana	Iasi
Romania	Clinica Natisan Pitesti	Pitesti
Romania	Cabinet Dr. Radulescu G. Mihaela Elena	Râmnicu Vâlcea
Romania	Pan Medical Sibiu	Sibiu
Romania	Cabinet Dr. Ioana Trotea Targu Jiu	Târgu Jiu
Romania	Clinica Medicala Dr. Cioata Ionel Trifon	Timisoara
Romania	Spitalul Judetean de Urgenta Tulcea	Tulcea

Sponsors (2)

Lead Sponsor	Collaborator
Perfect Care Distribution	MDX Research

Country where clinical trial is conducted

Romania, 

References & Publications (6)

Brown H, Drexler M. Improving the Diagnosis of Vulvovaginitis: Perspectives to Align Practice, Guidelines, and Awareness. Popul Health Manag. 2020 Oct;23(S1):S3-S12. doi: 10.1089/pop.2020.0265. — View Citation

Coudray MS, Madhivanan P. Bacterial vaginosis-A brief synopsis of the literature. Eur J Obstet Gynecol Reprod Biol. 2020 Feb;245:143-148. doi: 10.1016/j.ejogrb.2019.12.035. Epub 2019 Dec 24. — View Citation

Hainer BL, Gibson MV. Vaginitis. Am Fam Physician. 2011 Apr 1;83(7):807-15. — View Citation

Owen MK, Clenney TL. Management of vaginitis. Am Fam Physician. 2004 Dec 1;70(11):2125-32. — View Citation

Saraf VS, Sheikh SA, Ahmad A, Gillevet PM, Bokhari H, Javed S. Vaginal microbiome: normalcy vs dysbiosis. Arch Microbiol. 2021 Sep;203(7):3793-3802. doi: 10.1007/s00203-021-02414-3. Epub 2021 Jun 13. — View Citation

Verstraelen H, Verhelst R, Vaneechoutte M, Temmerman M. Group A streptococcal vaginitis: an unrecognized cause of vaginal symptoms in adult women. Arch Gynecol Obstet. 2011 Jul;284(1):95-8. doi: 10.1007/s00404-011-1861-6. Epub 2011 Feb 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of the medical device	the number of possible adverse Number of reactions observed during the treatment	3 months
Secondary	Improvement in the vaginal discharge aspect	Presence/absence of abnormal/normal vaginal discharge	3 months
Secondary	Improvement in the association of vaginal symptoms (burn and pain)	Presence/absence of vaginal symptoms (burn and pain)	3 months
Secondary	Improvement in vaginal irritation	Presence/absence of vaginal irritation	3 months
Secondary	Measurement of vaginal pH	Normalization of vaginal pH values	3 months