Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Oct 9:101:100762.
doi: 10.1016/j.curtheres.2024.100762. eCollection 2024.

Clinical Performance and Safety of Cerviron® Vaginal Ovules in the Management of Symptomatic Cervical Lesions: A National, Multicentric Study

Izabella Petre  1 , Daniela Oana Toader  2   3 , Ramona Petrita  4 , Alexandru-Remus Pinta  4 , Andreea-Anda Alexa  5 , Romina Georgiana Bita  6
Affiliations

Clinical Performance and Safety of Cerviron® Vaginal Ovules in the Management of Symptomatic Cervical Lesions: A National, Multicentric Study

Izabella Petre et al. Curr Ther Res Clin Exp. .

Abstract

Background: Cervical ectropion is frequently associated with vaginal symptoms requiring therapeutic intervention. However, no scientific consensus has been reached regarding the use of local re-epithelialization therapy to prevent severe bleeding, wound inflammation, and infection of cervical lesions.

Objective: The aim of our study was to investigate the aspect of the cervix by colposcopy after a 3-month treatment with an intravaginal medical device in the context of postoperative care of the symptomatic ectropion. The study analyzed additional clinical parameters, such as the evolution of primary and secondary inflammation and the degree of cervical epithelialization as secondary objectives.

Methods: Our pilot study included 27 participants with symptomatic cervical ectopy, with or without an associated human papillomavirus infection. The treatment protocol consisted of the monthly delivery of the medical device intravaginally, during day 1 to day 15, with a total study duration of 3 months.

Results: The medical device had a positive impact on cervical epithelialization, in terms of aspect of the cervix returning to normal for 100% of the participants. Between study visits, it was observed that primary inflammation was reduced by 85.19%, whereas vaginal ulceration, colpitis, and leukorrhea were improved by 70.37%, 81.48%, and by 66.67%, respectively.

Conclusions: The degree of cervical epithelialization reflects how well the cervix has healed after an injury or infection. The device showed clinical performance in complete re-epithelialization after surgical procedures. Moreover, our study findings suggest that supportive treatment with this intravaginal medical device can be recommended for cervical wound healing in patients with human papillomavirus infection. ClinicalTrials.gov identifier: NCT04735718.

Keywords: cervical ectopy; cervical epithelialization; human papillomavirus; medical device; postoperative care; vaginal bleeding.

PubMed Disclaimer

Conflict of interest statement

R.P. is currently employed at MDX Research. A.R.P. provided statistical input while working for MDX Research. MDX Research was involved in the study design, site selection, collection, statistical analysis, and preparation of the manuscript. The authors have indicated that they have no other conflicts of interest regarding the content of this article.

Figures

Fig 1
Fig. 1
Study flowchart.
Fig 2
Fig. 2
Study architecture.
Fig 3
Fig. 3
Improvement of scores after 30 days of treatment with Cerviron (A) bleeding; (B) malodour; (C) dysuria; (D) in dyspareunia; (E) in pain; (F) in leucorrhea.
Fig 4
Fig. 4
Participant satisfaction score—Likert scale.
See this image and copyright information in PMC

Similar articles

See all similar articles

References

    1. De Tomasi JB, Opata MM, Mowa CN. Immunity in the cervix: interphase between immune and cervical epithelial cells. J Immunol Res. 2019;2019:1–13. - PMC - PubMed
    1. Kleppa E, Holmen SD, Lillebø K, et al. Cervical ectopy: associations with sexually transmitted infections and HIV. A cross-sectional study of high school students in rural South Africa. Sex Transm Infect. 2015;91:124–129. - PMC - PubMed
    1. Lu Z, Chen H, Zheng X-M, Chen M-L. Expression and clinical significance of high risk human papillomavirus and invasive gene in cervical carcinoma. Asian Pac J Trop Med. 2017;10:195–200. - PubMed
    1. Graham SV. The human papillomavirus replication cycle, and its links to cancer progression: a comprehensive review. Clin Sci. (Lond) 2017;131:2201–2221. - PubMed
    1. Merera D, Jima GH. Precancerous cervical lesions and associated factors among women attending cervical screening at Adama Hospital Medical College, Central Ethiopia. Cancer Manag Res. 2021;13:2181–2189. - PMC - PubMed

Associated data

LinkOut - more resources