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Completed
NCT05652959
Real-world Performance and Safety of Cerviron® in the Treatment of Vaginitis
Conditions: Vaginitis, Bacterial Vaginosis
Sex: Female
Enrollment: 111
Sponsor: Perfect Care Distribution
Location: Romania
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.
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.
Source: ClinicalTrials.gov (NCT05652959). StuddyBuddy aggregates publicly available trial information.
