Evaluation of the Medical Device Vagitab - T as Adjuvant Therapy in Patients With Bacterial Vaginosis.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorS.I.I.T. Srl
About this trial
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.
Eligibility criteria
Qualifiers
Female patients aged from 18 to 65 years (inclusive).
Patients affected at enrolment by BV diagnosed according to Amsel criteria, candidate to start an antibiotic therapy with metronidazole.
Patient with a medical history of RBV (at least 2 episodes of BV in the last 12 months including the current episode).
Patients who are, in the opinion of the Investigator, able to understand the study, cooperate with the study procedures and attend all the study visits.
Disqualifiers
Patient with a medical history of HIV or any other immunodeficiency.
Patients working as sex workers.
Patients with known allergies or intolerance / hypersensitivity to the tested medical device and its components.
Patients with concomitant menstrual bleeding at baseline.
Trial design
Treatments tested in this trial
- Vagitab -T vaginal tablets. Components: tyndallized probiotic L. plantarum HA-119, lactic acid, and xylo-oligosaccharides, lauryl glucoside, and macrogol 3350:
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
S.I.I.T. Srl
Lead sponsor
Opera CRO, a TIGERMED Group Company
Collaborator
Source ClinicalTrials.gov