Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
FEMALE
NCT06725888

Evaluation of the Medical Device Vagitab - T as Adjuvant Therapy in Patients With Bacterial Vaginosis.

Led by S.I.I.T. Srl · Updated on 2025-05-28

30

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

S

S.I.I.T. Srl

Lead Sponsor

O

Opera CRO, a TIGERMED Group Company

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Evaluation of the Medical Device Vagitab - T as Adjuvant Therapy in Patients With Bacterial Vaginosis.

Who Can Participate

Age: 18Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged from 18 to 65 years (inclusive).
  • Diagnosed with bacterial vaginosis (BV) by Amsel criteria and starting metronidazole antibiotic treatment.
  • History of recurrent bacterial vaginosis with at least two episodes in the past 12 months including current.
  • Able to understand and cooperate with study procedures and attend all visits.
  • Provided written informed consent to participate in the study.
Not Eligible

You will not qualify if you...

  • History of HIV or other immunodeficiency.
  • Working as sex workers.
  • Known allergies or intolerance to Vagitab-T or its components.
  • Having menstrual bleeding at the start of the study.
  • Less than or equal to 3 days since last menstrual period before starting metronidazole.
  • Pregnant, breastfeeding, or planning pregnancy without using contraception during the study.
  • Using vaginal tampons.
  • Using etonogestrel/ethinyl estradiol vaginal rings or intrauterine devices.
  • Using oral or vaginal antibiotics besides metronidazole or other vaginal therapies like douching or spermicide.
  • Using oral or vaginal probiotics.
  • Any medical condition that could affect participation or cause hospitalization.
  • Participation in another interventional clinical trial within the last 30 days or currently.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Gyniclinique - Strada Johann Wolfgang von Goethe nr. 2

Timișoara, Timiș County, Romania, 300006

Actively Recruiting

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Research Team

F

Francesca Montarolo, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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