Using Vagitab-T to treat bacterial vaginosis

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 study is testing if a new vaginal tablet called Vagitab-T can help people with bacterial vaginosis feel better and prevent it from coming back.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Female
• Sponsor: S.I.I.T. Srl (Industry-sponsored)
• Locations: 1 site (Timișoara, Timiș County)
• Trial ID: NCT06725888 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of Vagitab-T, a vaginal tablet, as an adjuvant therapy for patients suffering from bacterial vaginosis (BV) and recurrent BV. All participants will receive Vagitab-T for three monthly cycles, alongside a seven-day course of metronidazole at the start of the study. The trial aims to assess the recurrence rate of BV, the restoration of normal vaginal flora, and improvements in vaginal secretions and quality of life. Participants will be monitored through visits and phone calls throughout the treatment period.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 65 with a history of recurrent bacterial vaginosis and currently diagnosed with BV.

Not a fit: Patients with immunodeficiencies, known allergies to the treatment components, or those currently experiencing menstrual bleeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the recurrence of bacterial vaginosis and improve the quality of life for affected patients.

How similar studies have performed: Previous studies have shown promising results with probiotic treatments for bacterial vaginosis, suggesting that this approach may be effective.

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 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.

Exclusion Criteria:

* 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 this trial is running

Timișoara, Timiș County

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

Study contacts

• Principal investigator: Attila Fogarassy, MD — Gyniclinique - Strada Johann Wolfgang von Goethe nr. 2 - Timisoara (Romania)
• Study coordinator: Francesca Montarolo, MD

Conditions Bacterial Vaginosis; Recurrent Bacterial Vaginosis; Vaginal microflora; Lactobacillus