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

CompletedOBSERVATIONAL
Enrollment

111

Participants

Timeline

Start Date

May 20, 2021

Primary Completion Date

March 20, 2022

Study Completion Date

May 30, 2022

Conditions
VaginitisBacterial Vaginosis
Interventions
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.

Trial Locations (10)

Unknown

Spitalul Clinic Dr. Ion Cantacuzino Bucharest, Bucharest

Med Life Humanitas Cluj-Napoca, Cluj-Napoca

Cabinet Medical - Dr. Saleh K. Majed, Craiova

Cabinet Medical - Dr. Surpanelu Oana, Iași

Clinica Natisan Pitesti, Piteşti

Cabinet Dr. Rădulescu G. Mihaela Elena, Râmnicu Vâlcea

Pan Medical Sibiu, Sibiu

Cabinet Dr. Ioana Trotea Targu Jiu, Târgu Jiu

Clinica Medicala Dr. Cioata Ionel Trifon, Timișoara

Spitalul Judetean de Urgenta Tulcea, Tulcea

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

MDX Research

NETWORK

lead

Perfect Care Distribution

INDUSTRY

NCT05652959 - Real-world Performance and Safety of Cerviron® in the Treatment of Vaginitis | Biotech Hunter | Biotech Hunter