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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT01471457
Eligibility Criteria:
Inclusion Criteria:
* Female
* Indications for initiation of pessary use and planning to be fitted for and wear a pessary
Exclusion Criteria:
* Male
* Already using a pessary or have used in the last year
* History of recurrent or chronic bacterial vaginosis with \> 2 episodes per year or symptoms reported for \> 6 months out of last year
* Active known vaginal infection (symptomatic and/or untreated) or completion of treatment for BV or cervical/vaginal infection within one week of recruitment
* History of active vaginal ulcerative disease (active ulcers from atrophy, herpes symptoms at recruitment, or HSV with \> 2 outbreaks per year or last outbreak \< 1 month ago)
* Chronic antibiotic use for indications not listed above
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01471457
Study Brief:
Protocol Section:
NCT01471457