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New treatment option for Bacterial Vaginosis (BV)
Official title Evaluation of the Medical Device Vagitab - T as Adjuvant Therapy in Patients With Bacterial Vaginosis.
ClinicalTrials.gov ID: NCT06725888
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65, women only
You may be able to join 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...
- Patients who have given their written informed consent to participate in the study.
You likely can't join 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...
See the full eligibility 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.
- 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 treatment clinical trials
The study team makes the final eligibility decision.
Where it's taking place
- Timișoara, Timiș County, Romania
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Timișoara, Timiș County, Romania. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.