NCT06725888 Evaluation of the Medical Device Vagitab - T as Adjuvant Therapy in Patients With Bacterial Vaginosis.
| NCT ID | NCT06725888 |
| Status | Recruiting |
| Phase | — |
| Sponsor | S.I.I.T. Srl |
| Condition | Bacterial Vaginosis (BV) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-03-31 |
| Primary Completion | 2025-09-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-03-31 with a primary completion date of 2025-09-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Attila Fogarassy, MD
PRINCIPAL INVESTIGATOR
Gyniclinique - Strada Johann Wolfgang von Goethe nr. 2 - Timisoara (Romania)
Frequently Asked Questions
Who can join the NCT06725888 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Bacterial Vaginosis (BV). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06725888 currently recruiting?
Yes, NCT06725888 is actively recruiting participants. Contact the research team at f.montarolo@siit-it.com for enrollment information.
Where is the NCT06725888 trial being conducted?
This trial is being conducted at Timișoara, Romania.
Who is sponsoring the NCT06725888 clinical trial?
NCT06725888 is sponsored by S.I.I.T. Srl. The principal investigator is Attila Fogarassy, MD at Gyniclinique - Strada Johann Wolfgang von Goethe nr. 2 - Timisoara (Romania). The trial plans to enroll 30 participants.