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A Safety, Tolerability and Preliminary Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis (IC) and Hunner's Lesions
NCT01879683 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of the study is to evaluate if LiRIS 400 mg is safe and tolerable when administered to women with Interstitial Cystitis with Hunner's lesions, and to evaluate any change in the bladder or in IC symptoms, following LiRIS administration.
Conditions Studied
Interventions
- DRUG LiRIS® 400 mg
Study Locations (2)
Florida
- Advance Urology Institute — Daytona Beach
Michigan
- William Beaumont Hospital — Royal Oak
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2013-07 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01879683
The ClinicalTrials.gov registry entry for NCT01879683 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allergan, which has 52 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Chronic Interstitial Cystitis appearing as the primary indexed condition, and to 1 intervention — of which LiRIS® 400 mg is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01879683 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Florida, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01879683 about?
NCT01879683 is a clinical study titled "A Safety, Tolerability and Preliminary Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis (IC) and Hunner's Lesions". The purpose of the study is to evaluate if LiRIS 400 mg is safe and tolerable when administered to women with Interstitial Cystitis with Hunner's lesions, and to evaluate any change in the bladder or in IC symptoms, following LiRIS administration.
What is the current status of trial NCT01879683?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2013-07. Estimated completion is 2014-06.
What conditions does trial NCT01879683 study?
This clinical trial studies the following conditions: Chronic Interstitial Cystitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01879683?
The interventions under investigation include: LiRIS® 400 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01879683?
This trial is sponsored by Allergan, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01879683 being conducted?
This trial has 2 study locations across Florida, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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