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

Recruiting now · Not applicable

Conditions studied: Bacterial Vaginosis (BV), Recurrent Bacterial Vaginosis

In brief

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.

Key facts

Study ID

NCT06725888

Run by

S.I.I.T. Srl

People needed

30

Starts

2025-03-31

Expected to finish

2025-09-30

Last updated by the study team

2025-05-28

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Patients who have given their written informed consent to participate in the study.

You may not qualify if…

• 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.
• Time between the last day of last menses and treatment with metronidazole ≤ 3 days.
• Pregnant, lactating, and lactating amenorrhoeic patients and patients of childbearing potential who are planning a pregnancy or unwilling to use appropriate methods of contraception during the study
• Concomitant use of vaginal tampons.
• Concomitant administration of etonogestrel/ethinyl estradiol vaginal rings or of intrauterine devices.
• Concomitant use of oral or vaginal antibiotic therapy (apart from metronidazole) or any other vaginal therapies or treatment (such as douching, spermicide).
• Concomitant use of oral or vaginal probiotics.
• Patients with any other medical condition that, in the opinion of the Investigator, would compromise participation or be likely to lead to hospitalization during the study.
• Concomitant or previous (in the previous 30 days) participation in any other interventional clinical trials

Where it is running

• Gyniclinique - Strada Johann Wolfgang von Goethe nr. 2 — Timișoara, Timiș County, Romania (enrolling)

Full record on ClinicalTrials.gov

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