Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT07247851
Eligibility Criteria:
Inclusion Criteria:
* Women aged ≥ 18 years with a clinical diagnosis and laboratory diagnosis as (cervical smear \& high vaginal swab) of bacterial vaginosis.
* Diagnosed with Bacterial vaginosis the Amsel scoring system which requires 3 criteria of 4 criteria for diagnosis.:
* The presence of homogeneous, thin, greyish white vaginal discharge.
* Vaginal pH over 4.5.
* Positive whiff-amine test (the presence of a fishy odor following addition of KOH to the vaginal sample).
* More than 20% clue cells/high power field on a wet mount of vaginal secretions.
Exclusion Criteria:
* Other types of infections based on history and clinical examination as candida vaginitis (itching with cottage cheese whitish discharge, Trichomonas vaginalis (with yellowish green offensive discharge) and any sexually transmitted disease (STDs) as gonorrhea(watery creamy greenish discharge, pain on micturation)syphilis(appearance of shung-kur ulcer, painless sore), chlamydia(abnormal discharge from vagina, burning sensation on peeing, abnormal discharge from penis) or genital herpes (tingling, burning, itching around genitals on both parteners).
* Pregnant and lactating females
* Any contraindication or hypersensitivity to metronidazole use
* Use of other antibiotics or systemic antifungal agents within the previous 2 weeks or planned use within 2 weeks
* Use of topical vaginal antibiotics, antifungals or acidifying products recently or planned within 2 weeks
* Atrophic vaginitis
* Using IUD as contraceptive method because IUD is a risk factor for infection
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07247851
Study Brief:
Protocol Section:
NCT07247851