Using Vagitab-T to treat bacterial vaginosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: f.montarolo@siit-it.com
• Phone: +39 02484352278

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Chlorhexidine and/or Metronidazole Plus FB301 Pre-treatment for Bacterial Vaginosis

  This study tests whether FB301, used with or after pre-treatments like chlorhexidine or metronidazole, can help restore healthy vaginal bacteria in women with BV.

  Recruiting at 2 sites Phase 2 Freya Biosciences ApS · Berlin, State of Berlin and 1 other locations · NCT07481955

• Can Lactobacillus crispatus CRP21 reduce recurrent bacterial vaginosis after antibiotics?

  This trial tests whether a probiotic capsule containing Lactobacillus crispatus CRP21 can lower recurrence of bacterial vaginosis in women after standard antibiotic treatment.

  Recruiting at 11 sites Liaquat University of Medical & Health Sciences · Forlì, Emilia-Romagna and 10 other locations · NCT07474831

• Transplanting vaginal microbiota to treat recurrent bacterial vaginosis

  This study is testing if a vaginal microbiota transplant can help women with recurring bacterial vaginosis feel better compared to a saline solution.

  Recruiting Phase 1/2 Massachusetts General Hospital · Boston, Massachusetts · NCT04046900

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.