Real-World Performance and Safety of Cerviron® Medical Device in the Treatment of Various Types of Vaginitis

 A total of 111 women aged between 20 and 70 years were in­cluded, who were treated with Cerviron® ovules as monotherapy and 40 who used Cerviron® ovules as supportive treatment in conjunction with antibiotic therapy. The aim of the 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. The results showed that Cerviron® ovules are well tolerated and effective as monotherapy and also as an adjuvant to antibiotic therapy. In the performance evaluation, specific symptomatology was analyzed: abnormal vaginal discharge, burning and/ or vaginal pain, vaginal irritation, abnormal smell and vaginal pH level balance. The results show that most of the patients reported a decrease or no presence of the above-mentioned symptoms after following a three months’ treatment. No persistence or worsening of symptoms / clinical signs were noted in any participant. The presence of vaginal symptoms has improved statistically significantly after 90 days. In terms of the degree of satisfaction offered, participants in the largest proportion (around 76.3%) said they were very satisfied with this medical device and 22.14% were satisfied. Only 1.43% of the total number of participants declared themselves neutral in terms of satisfaction.

Real‑world study of Cerviron® vaginal ovules in the treatment of cervical lesions of various etiologies

The present study assessed the post‑market performance and tolerability of Cerviron® ovules in the treatment and management of cervical lesions postoperatively. The study population included 345 participants aged 20‑70 years with either a cervical lesion under treatment or with recent surgical removal of a cervical lesion. The degree of re‑epithelialization of the cervical mucosa was improved in 73.17% of the patients evaluated during routine colposcopy exams and 92.73% of patients recorded no bleeding. When adding Cerviron® either as monotherapy or in association with other antimicrobials in postoperative care of the cervical ectropion, improved postoperative outcomes such as reduced post‑interventional bleeding and a superior quality of healing were observed.

Clinical Performance and Safety of Cerviron® Vaginal Ovules in the Management of Symptomatic Cervical Lesions: A National, Multicentric Study

The aim the study was to investigate the aspect of the cervix by colposcopy after a 3-month treatment with Cerviron® in the context of postoperative care of the symptomatic ectropion. The study analyzed additional clinical parameters, such as the evolution of primary and secondary inflammation and the degree of cervical epithelialization as secondary objectives. The pilot study included 27 participants with symptomatic cervical ectopy, with or without an associated human papillomavirus infection. The treatment protocol consisted of the monthly delivery of the medical device intravaginally, during day 1 to day 15, with a total study duration of 3 months. The medical device had a positive impact on cervical epithelialization, in terms of aspect of the cervix returning to normal for 100% of the participants. Between study visits, it was observed that primary inflammation was reduced by 85.19%, whereas vaginal ulceration, colpitis, and leukorrhea were improved by 70.37%, 81.48%, and by 66.67%, respectively. The degree of cervical epithelialization reflects how well the cervix has healed after an injury or infection. The device showed clinical performance in complete re-epithelialization after surgical procedures. Moreover, our study findings suggest that supportive treatment with this intravaginal medical device can be recommended for cervical wound healing in patients with human papillomavirus infection.