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NCT00109512 · ClinicalTrials.gov registry record · Phase 2

Endometriosis Trial: Study of NBI-56418 in Endometriosis

A Phase 2 study of Endometriosis, sponsored by Abbott.

Completed
Registry status
Phase 2
Development phase
76
Enrollment target
15
Study locations

NCT00109512: Completed Phase 2 study of Endometriosis, sponsored by Abbott.

NCT00109512 is a Phase 2 study of Endometriosis that has completed, run by Abbott. The registered enrollment target is 76 participants, below the 263-participant average among 48 other Endometriosis trials with a reported enrollment target (71% lower). The trial reports 15 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00109512, a Phase 2 study of Endometriosis, has completed, sponsored by Abbott.

COMPLETED
Registry status
Phase 2
Development phase
76 participants
Enrollment target
15
Study locations

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.

Primary Outcome

This scale is used to assess the signs (pelvic tenderness and induration) and symptoms (nonmenstrual pelvic pain, dysmenorrhea and dyspareunia) associated with endometriosis.

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
Abbott

181 total trials

What the finished NCT00109512 record still lists

NCT00109512 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 263-participant average among 48 other Endometriosis trials with a reported enrollment target (71% lower).

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.

NCT00109512 lists 15 locations in 10 states (Illinois, California, Virginia).

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.

What interventions are being tested in trial NCT00109512?

The interventions under investigation include: placebo (DRUG), NBI-56418 (GnRH antagonist) (DRUG).

Who is sponsoring clinical trial NCT00109512?

This trial is sponsored by Abbott, which has 181 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Endometriosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00109512's enrollment target sits among peer trials

76 29th of 48 higher than 20 of 48 other Endometriosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Endometriosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00109512, the US trial registry maintained by the National Library of Medicine. NCT00109512 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.