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Clinical Investigation To Evaluate Cerviron Ovules® in Symptomatic Vaginitis

NCT04735705 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-11-22

Study results available
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Summary

CYRON is a Prospective, Open-Label, Pilot, Multicentric Clinical Investigation to Evaluate the Performance and Safety of Cerviron Ovules® in the Local Treatment of Non-Specific or Endogenous, Symptomatic Vaginitis. The primary objective is to assess the therapeutic performance and tolerability of Cerviron® Ovules in patients with symptomatic, non-specific, non-infectious vaginitis, and endogenous symptomatic infections.

The secondary objective of this clinical investigation is the assessment of performance of the medical device by several additionally clinical outcomes (vaginal discharge, vaginal pH, microscopic characteristics of inflammatory cells and characteristics of vaginal microflora).

Participants will also evaluate the degree of satisfaction related to the use of the medical device.

Conditions

  • Vaginitis and Vulvovaginitis

Interventions

DEVICE

Cerviron

Cerviron ovules ® is a class IIb medical device indicated 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. It is also used in cervical lesions of mechanical origin as it favors the healing and re-epithelialization processes and reduces the proliferation of endogenous pathogens.

Sponsors & Collaborators

  • MDX Research

    collaborator NETWORK

  • Perfect Care Distribution

    lead INDUSTRY

Principal Investigators

  • Ramona Petrita, CSO · MDX Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2021-09-09
Completion
2021-09-09

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04735705 on ClinicalTrials.gov