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 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT03357666
Eligibility Criteria:
Inclusion Criteria:
1. Fertile women
2. Clinical diagnosis of bacterial vaginosis with criteria on below (3 out of 4 fulfilled criteria)
* light gray adherent vaginal discharge
* pH \>4.5
* Presence of clue cells ≥20%
* Positive "10% KOH whiff test"
3. Nugent Score ≥ 4
Exclusion Criteria:
1. Pregnant or breast-feeding patient or planning pregnancy
2. Patient with candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex virus infection
3. Patient who received antifungal or antimicrobial therapy (systemic or intravaginal) within 30 days of randomization
4. Any condition or circumstance that would interfere with analysis of study results
5. Patient who have a plan to treat other disease (e.g cervical carcinoma) during clinical study period
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
19 Years
Maximum Age:
50 Years
Study:
NCT03357666
Study Brief:
Protocol Section:
NCT03357666