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Endometriosis Trial: Study of NBI-56418 in Endometriosis
NCT00109512 · View on ClinicalTrials.gov ↗
Study Summary
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study with subjects randomized to one of three treatment groups, placebo, 75 mg and 150 mg in a 1:1:1 ratio. Study drug was administered once daily for 12 weeks. After the last dose at the end of Week 12, follow-up continued every 4 weeks for 12 weeks.
Conditions Studied
Interventions
- DRUG placebo
- DRUG NBI-56418 (GnRH antagonist)
Study Locations (15)
Illinois
- Site Reference ID/Investigator# 56270 — Champaign
- Site Reference ID/Investigator# 56273 — Chicago
- Site Reference ID/Investigator# 56269 — Oak Brook
- Site Reference ID/Investigator# 56271 — Peoria
California
- Site Reference ID/Investigator# 55210 — San Diego
- Site Reference ID/Investigator# 55214 — San Ramon
Virginia
- Site Reference ID/Investigator# 56274 — Richmond
- Site Reference ID/Investigator# 55212 — Virginia Beach
Arizona
- Site Reference ID/Investigator# 56266 — Phoenix
Florida
- Site Reference ID/Investigator# 56267 — Clearwater
Kentucky
- Site Reference ID/Investigator# 56272 — Louisville
North Carolina
- Site Reference ID/Investigator# 55213 — Winston-Salem
Texas
- Site Reference ID/Investigator# 55211 — Arlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2005-04 |
| Est. Completion | 2006-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00109512
The ClinicalTrials.gov registry entry for NCT00109512 describes a study currently listed as completed. It is categorized as Phase 2, 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 76 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott, which has 43 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 Endometriosis appearing as the primary indexed condition, and to 2 interventions — of which placebo 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: NCT00109512 reports 15 study locations spanning 10 distinct geographic areas — top geographies include Illinois, California, Virginia. 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 NCT00109512 about?
NCT00109512 is a clinical study titled "Endometriosis Trial: Study of NBI-56418 in Endometriosis". This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study with subjects randomized to one of three treatment groups, placebo, 75 mg and 150 mg in a 1:1:1 ratio. Study drug was administered once daily for 12 weeks. After the last dose at the end of Week 12, f...
What is the current status of trial NCT00109512?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2005-04. Estimated completion is 2006-06.
What conditions does trial NCT00109512 study?
This clinical trial studies the following conditions: Endometriosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00109512?
The interventions under investigation include: placebo (DRUG), NBI-56418 (GnRH antagonist) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00109512?
This trial is sponsored by Abbott, which has 43 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00109512 being conducted?
This trial has 15 study locations across Arizona, California, Florida, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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