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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT04885556
Eligibility Criteria:
Inclusion Criteria:
* Heterosexual
* Age 25-50
* Has used tampons in the past 5 years
* Sexually active (vaginal intercourse, minimum once per week)
* Answered "moderate" to "severe" to being bothered by dripping/discomfort on Patient Global Impression of Severity (PGI-S) questionnaire "on minutes, hours, or following day"
* Willing and able to use product
* Understands, reads, writes, and speaks English
Exclusion Criteria:
* Pregnant
* Currently using condoms
* Unable to use device due to poor motor function
* Chronic disease which makes prone to infection (diabetes, autoimmune)
* Recurrent yeast infections
* Recurrent Urinary tract infection (UTI) (\>2 within the past year)
* Diagnosis of pelvic organ prolapse (Stage II or greater)
* Previous pelvic or vaginal surgery which, in the opinion of the investigator, may prevent proper use of product
* Unable to sign informed consent
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
25 Years
Maximum Age:
50 Years
Study:
NCT04885556
Study Brief:
Protocol Section:
NCT04885556