Real-world Performance and Safety of Cerviron® in the Treatment of Vaginitis
NCT ID: NCT05652959
Last Updated: 2023-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
111 participants
OBSERVATIONAL
2021-05-20
2022-05-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Negative result for Gardnerella vaginalis, Candida albicans, Trichomonas vaginalis.
Exclusion Criteria
* Subject with vulvar, vaginal or cervical cancer;
* Subjects with other inflammatory gynecological conditions.
18 Years
65 Years
FEMALE
No
Sponsors
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MDX Research
NETWORK
Perfect Care Distribution
INDUSTRY
Responsible Party
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Principal Investigators
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Ema Peta
Role: STUDY_DIRECTOR
Perfect Care Distribution
Locations
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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
Iași, , Romania
Clinica Natisan Pitesti
Piteşti, , Romania
Cabinet Dr. Rădulescu 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
Timișoara, , Romania
Spitalul Judetean de Urgenta Tulcea
Tulcea, , Romania
Countries
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References
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Hainer BL, Gibson MV. Vaginitis. Am Fam Physician. 2011 Apr 1;83(7):807-15.
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.
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.
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.
Owen MK, Clenney TL. Management of vaginitis. Am Fam Physician. 2004 Dec 1;70(11):2125-32.
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.
Other Identifiers
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CYRONRW/01/2022
Identifier Type: -
Identifier Source: org_study_id
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