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 @ 7:19 PM
Ignite Modification Date:
2025-12-24 @ 7:19 PM
NCT ID:
NCT01824303
Eligibility Criteria:
Inclusion Criteria
Blinded study:
* Women age 18 and over
* Diagnosed with Interstitial Cystitis as defined by protocol
* Able to report IC symptoms of bladder pain, voiding habits, as required by protocol, and record in diary
* Able to comply with visit schedule and diary completion at home
Open-label Extension:
* Must have completed the blinded study prior to screening for the Open-label extension
Exclusion Criteria (Blinded and Open-Label Extension):
* Pregnant or lactating women
* History or presence of any condition that would make it difficult to accurately evaluate bladder symptoms
* Bladder or urethral abnormality that would prevent safe insertion of investigational product
* Requiring medication not allowed per study protocol
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01824303
Study Brief:
Protocol Section:
NCT01824303