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

NCT05652959 | Completed

• 1 other identifier: CYRONRW/01/2022
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Vaginitis; Bacterial Vaginosis

Keywords

vulvovaginitis; vaginal discharge; vaginal pH

Outcome Measures

Primary Outcomes (1)

• Safety of the medical device

  the number of possible adverse Number of reactions observed during the treatment

  3 months

Secondary Outcomes (4)

• Improvement in the vaginal discharge aspect

  3 months

• Improvement in the association of vaginal symptoms (burn and pain)

  3 months

• Improvement in vaginal irritation

  3 months

• Measurement of vaginal pH

  3 months

Interventions

Cerviron® DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Vaginitis is a common problem for women of all ages.
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women aged between 20 and 70 years were treated with Cerviron® ovules as monotherapy and Cerviron® ovules as supportive treatment in conjunction with the antibiotic therapy having specific symptoms such as leukorrhea, vaginal itching, pain and a feeling of tension, vaginal burning, erythema, abnormal odor of vaginal secretions, dysuria and dyspareunia.

You may qualify if:

• 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.

You may not qualify if:

• Subjects with diagnosed abnormal genital bleeding;
• Subject with vulvar, vaginal or cervical cancer;
• Subjects with other inflammatory gynecological conditions.

Sponsors & Collaborators

• Perfect Care Distribution: lead
• MDX Research: collaborator

Study Sites (10)

Spitalul Clinic Dr. Ion Cantacuzino Bucharest

Bucharest, Romania

Location

Med Life Humanitas Cluj-Napoca

Cluj-Napoca, Romania

Location

Cabinet Medical - Dr. Saleh K. Majed

Craiova, Romania

Location

Cabinet Medical - Dr. Surpanelu Oana

Iași, Romania

Location

Clinica Natisan Pitesti

Piteşti, Romania

Location

Cabinet Dr. Rădulescu G. Mihaela Elena

Râmnicu Vâlcea, Romania

Location

Pan Medical Sibiu

Sibiu, Romania

Location

Cabinet Dr. Ioana Trotea Targu Jiu

Târgu Jiu, Romania

Location

Clinica Medicala Dr. Cioata Ionel Trifon

Timișoara, Romania

Location

Spitalul Judetean de Urgenta Tulcea

Tulcea, Romania

Location

Related Publications (6)

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

  PMID: 21524046 BACKGROUND

• 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.

  PMID: 34120200 BACKGROUND

• 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.

  PMID: 21336834 BACKGROUND

• 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.

  PMID: 31901667 BACKGROUND

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

  PMID: 15606061 BACKGROUND

• 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.

  PMID: 32997581 BACKGROUND

MeSH Terms

Conditions

Vaginitis; Vaginosis, Bacterial; Vulvovaginitis; Vaginal Discharge

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vulvitis; Vulvar Diseases

Study Officials

• Ema Peta

  Perfect Care Distribution

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: December 15, 2022
• Study Start: May 20, 2021
• Primary Completion: March 20, 2022
• Study Completion: May 30, 2022
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

RO (10)