Clinical trial NCT05652959: Real-world Performance and Safety of Cerviron® in the Treatment of Vaginitis
Official title: Real-world Performance and Safety of Cerviron® Medical Device in the Treatment of Various Types of Vaginitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginitis
Bacterial Vaginosis
Keywords: vulvovaginitis
vaginal discharge
vaginal pH
Lead sponsor: Perfect Care Distribution
Sponsor class: INDUSTRY
Collaborators: name: MDX Research
First posted: 2022-12-15
Enrollment: 111
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: This study was designed as real-world evidence study with the primary purpose to assess the performance and tolerance of Cerviron® ovules in the treatment and management of various types of vulvovaginitis. The study collected clinical data from 28 different specialized gynecology clinical facilities. The study was conducted between May 20, 2021 and August 31, 2021.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Safety of the medical device
timeFrame: 3 months
Secondary outcomes:
measure: Improvement in the vaginal discharge aspect
timeFrame: 3 months
measure: Improvement in the association of vaginal symptoms (burn and pain)
timeFrame: 3 months
measure: Improvement in vaginal irritation
timeFrame: 3 months
measure: Measurement of vaginal pH
timeFrame: 3 months
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Spitalul Clinic Dr. Ion Cantacuzino Bucharest
city: Cluj-Napoca
country: Romania
facility: Med Life Humanitas Cluj-Napoca
city: Craiova
country: Romania
facility: Cabinet Medical - Dr. Saleh K. Majed
city: Iaşi
country: Romania
facility: Cabinet Medical - Dr. Surpanelu Oana
city: Piteşti
country: Romania
facility: Clinica Natisan Pitesti
city: Râmnicu Vâlcea
country: Romania
facility: Cabinet Dr. Rădulescu G. Mihaela Elena
city: Sibiu
country: Romania
facility: Pan Medical Sibiu
city: Timişoara
country: Romania
facility: Clinica Medicala Dr. Cioata Ionel Trifon
city: Tulcea
country: Romania
facility: Spitalul Judetean de Urgenta Tulcea
city: Târgu Jiu
country: Romania
facility: Cabinet Dr. Ioana Trotea Targu Jiu
Study officials:
affiliation: Perfect Care Distribution
name: Ema Peta
role: STUDY_DIRECTOR
References:
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citation: 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.
citation: 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.
citation: Owen MK, Clenney TL. Management of vaginitis. Am Fam Physician. 2004 Dec 1;70(11):2125-32.
citation: 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.