/ Not yet recruitingNot Applicable A Prospective, Multicentre, Open-label, Study to Assess Performance and Safety of the Medical Device Vagitab - T in Rebalancing the Altered Vaginal Flora As Adjuvant Therapy in Patients with Bacterial Vaginosis and in Reducing Incidence of Recurrence During a 3-months Period of Follow-up.
This clinical trial is looking at how well and safely the vaginal administration of Vagitab-T works . Vagitab-T is already on the market in several countries in Europe as a medical device.
The main goals of this trial are to see if the recurrence rate of bacterial vaginosis goes down during the study, if it helps balance the altered vaginal flora during antibiotic treatment, if it improves vaginal secretions, and if vaginal microflora return to normal. We'll also ask the participants about their quality of life and whether they think the treatment is safe.
All 30 women will get the same treatment, and there's no comparison group. They'll be treated with Vagitab-T vaginal tablets for three monthly cycles. Also, metronidazole will be taken at the start of the study for seven days.
Participants will sign an informed written consent and we'll visit them at the start (day 0) and end (day 90) of the study. In addition, we'll call them during each of the three cycles of treatment.
100 Clinical Results associated with S.I.I.T. S.r.l.
0 Patents (Medical) associated with S.I.I.T. S.r.l.
100 Deals associated with S.I.I.T. S.r.l.
100 Translational Medicine associated with S.I.I.T. S.r.l.