Clinical studies

Clinical studies

Ongoing clinical trials

Several clinical trials are currently underway to track the performance and safety of the Cerviron® medical device.

CYRON/01/2021 aims to assess the therapeutic effect of Cerviron® ovules in patients with symptomatic, non-specific, non-infectious vaginitis, as well as in patients with symptomatic infections caused by specific vaginal flora imbalance. The study will also evaluate the improvement of additional clinical parameters, namely vaginal secretion, vaginal pH, the appearance of inflammatory cells and the characteristics of vaginal microflora). The Cerviron® medical device will be administered for 3 consecutive months to patients aged 18-65 years who have vaginal symptoms such as leucorrhoea, pruritus, burning sensation, local redness, pain, or unpleasant odour.

CYRON/02/2021 will study the therapeutic effects of Cerviron® ovules in the postoperative care of patients who have undergone surgical removal of benign cervical lesions in the absence of HPV infection. Secondary, the progression of lesions to clinical examination and patient satisfaction with the use of the medical device will be assessed. In this clinical investigation, the recommended dose is 1 ovule of Cerviron® administered intravaginally, from the first day after menstruation to day 15, for a period of 3 consecutive months.

Each clinical trial will enrol 50 volunteers. The studies were submitted to the National Agency for Medicines in Romania and to the Bioethics Committee for Medicines and Medical Devices and published on the platform dedicated to clinical trials, www.clinicaltrials.gov, with the identification numbers NCT04735705 and NCT04735718, respectively. The results are expected to be published in the first quarter of 2022.

The links are:

Need more information? Don’t hesitate to contact us!

info@cerviron.com

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