Clinical performance and safety of Cerviron^®vaginal ovules in the local treatment of non-specific vaginitis: a national, multicentric clinical investigation

Abstract

Purpose Non-specific vaginitis is a distinct clinical entity with particular microscopic and immunologic features. Currently, there is no standard of care for women with non-specific vaginitis. The aim of our study was to assess the change in vaginal symptoms score after a 3-months treatment with Cerviron medical device in participants with abnormal vaginal discharge and with specific signs and symptoms. As secondary objectives, the study analyzed other clinical and microscopic features, such as vaginal discharge aspect, change in vaginal pH, change in vaginal microbiome, and vaginal inflammation. Methods The study population included 47 participants suffering from symptomatic vulvovaginitis, distinct from candidiasis, trichomoniasis or bacterial vaginosis. The study design included 2 research sites from Romania. The treatment protocol consisted of 1 ovule/day inserted intravaginally, during 15 consecutive days. The total study duration was 3 months. Findings Cerviron had a positive impact on the vaginal symptoms score for 72.34% of the study participants. Topical administration of Cerviron balanced vaginal pH values and significantly reduced signs of inflammation between study visits. Implications Cerviron shows curative effects that supports its use as a stand-alone treatment in women with non-specific vaginitis. ClinicalTrials.gov identifier:NCT04735705. A second clinical investigation is ongoing to evaluate its clinical efficacy in postoperative care of cervical and vaginal wounds, traumatic or secondary to surgical interventions.