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CompletedNCT00109512

Endometriosis Trial: Study of NBI-56418 in Endometriosis

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of NBI-56418 in Endometriosis

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
76 (actual)
Sponsor
Abbott · Industry
Sex
Female
Age
18 Years – 49 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGNBI-56418 (GnRH antagonist)
DRUGplacebo

Timeline

Start date
2005-04-01
Primary completion
2006-06-01
Completion
2006-06-01
First posted
2005-04-29
Last updated
2012-02-22

Locations

15 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00109512. Inclusion in this directory is not an endorsement.

Endometriosis Trial: Study of NBI-56418 in Endometriosis (NCT00109512) · Clinical Trials Directory