Clinical studies

Clinical studies

Ongoing clinical trials

Several clinical studies were conducted to evaluate the performance and safety of the administration of the CERVIRON medical device.

CYRON/01/2021 aimed to evaluate the therapeutic performance of Cerviron in patients with symptomatic, non-specific and non-infectious vaginitis and symptomatic endogenous infections.

The evaluation of the performance of the medical device was also assessed by the analysis of several clinical parameters (vaginal discharge, vaginal pH, microscopic characteristics of the inflammatory cells and the characteristics of the vaginal microflora). The participants in this study also evaluated the degree of satisfaction related to the use of Cerviron.

The medical device Cerviron® was administered for 3 consecutive months, 15 days, to patients aged between 18 and 65 years and presenting vaginal symptoms, such as leukorrhea, itching, burning sensation, local redness, pain, unpleasant odor, dysuria or dyspareunia.

Primary study results showed that for 72.34% of study participants who used Cerviron, the medical device had a significant beneficial effect on symptom relief. Significant improvements were also observed in the aspect of vaginal secretion, pH values and vaginal inflammation score. improvements in vaginal microflora and lactobacilli count were observed but they were not statistically significant.

In conclusion, the administration of Cerviron vaginal ova over a period of 3 months significantly alleviates the symptoms of symptomatic, non-specific, non-infectious vaginitis and symptomatic endogenous infections, and its administration is considered safe.

CYRON/02/2021 studied the effects of Cerviron® ovules in the postoperative care of patients who underwent surgical excision of benign cervical lesions in the absence of HPV infection. Secondary, the evolution of the lesions during the clinical examination and the degree of satisfaction of the patients related to the use of the medical device was evaluated.

In this clinical investigation, the recommended dose is 1 Cerviron® ovule administered intravaginally, from the first day after menstruation until day 15, over a period of 3 consecutive months.

The study showed that Cerviron® is an excellent adjuvant for accelerating the healing of cervical erosions. It favors the re-epithelialization of the damaged tissue and the restoration of the original colpo-ecosystem. Topical application has been effective in minimizing inflammation after surgical procedures and also in reducing unpleasant symptoms such as vaginal discharge.

In terms of adverse events, the medical device is considered safe with no reported adverse reactions.

Cerviron® ovules offer the advantage of scarless wound healing, tissue repair and regeneration and can be considered as a promising adjunctive therapy in postoperative care.

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