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 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT02515656
Eligibility Criteria:
Inclusion Criteria:
* Patient with an abnormal vaginal discharge associated with one (or more) functional vaginal complaints: vaginal burning and/or vaginal pain and/or vaginal irritation clinically evoking an infectious vaginitis:
* bacterial vaginitis
* non-specific vaginitis (atypical symptoms)
* mixed vaginitis (i.e. suprainfected fungal vaginitis) and able to receive an empirical local treatment
Exclusion Criteria:
1. Recurrent patient; i.e. a patient who has had at least 4 episodes of infectious vaginitis in the 12 months prior to inclusion
2. Vaginal infection justifying systemic therapy
3. History of atrophic vaginitis or suspected atrophic vaginitis at inclusion
4. Patient presenting with signs of genital herpes or signs of non-infectious vulvar pathology (vulvodynia, psoriasis, eczema, lichen sclerosus, lichen planus, contact dermatitis, candida intertrigo, vulval intraepithelial neoplasia (VIN))
5. Patient with current Sexually Transmitted Infection (STI) and/or patients with clinical suspicion of STI
6. Disease or concomitant treatment that could cause decreased immunity (i.e. diabetes mellitus, corticosteroids treatments)
7. Systemic anti-infective treatment (antibiotic, antifungal) within two weeks prior to inclusion
8. Patient menstruating or patient with menometrorrhagia due to hormonal imbalance at the time of inclusion
9. Pregnant or lactating women or delivery within last 1 month
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT02515656
Study Brief:
Protocol Section:
NCT02515656