Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 2

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

FieldValue
Enrollment Target 76 participants
Start Date 2005-04
Est. Completion 2006-06
Phase Phase 2

Sponsor

Abbott

43 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial