Evaluation of the Medical Device Vagitab - T as Adjuvant Therapy in Patients With Bacterial Vaginosis.
Recruiting
N/A
Interventional Study
Bacterial Vaginosis (BV)
Recurrent Bacterial Vaginosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 65
- Sex
- Female
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- S.I.I.T. Srl · Industry
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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 vagina…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 mo…
Contacts