Endometriosis Trial: Study of NBI-56418 in Endometriosis

Phase 2

Completed

• Conditions: Endometriosis
• Interventions: Drug: placebo; Drug: NBI-56418 (GnRH antagonist)

• Registration Number: NCT00109512
• Lead Sponsor: Abbott

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-04-28
• Study First Submitted QC: 2005-04-28
• Study First Posted: 2005-04-29
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-21
• Last Update Posted: 2012-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
NBI-56418 75 mg	NBI-56418 (GnRH antagonist)	-
NBI-56418 150 mg	NBI-56418 (GnRH antagonist)	-

Primary Outcome Measures

Name	Time	Method
Total Composite Pelvic Signs and Symptom Scale (CPSSS) scores	Every 4 weeks	This scale is used to assess the signs (pelvic tenderness and induration) and symptoms (nonmenstrual pelvic pain, dysmenorrhea and dyspareunia) associated with endometriosis.

Secondary Outcome Measures

Name	Time	Method
Electrocardiogram (ECG) tracings	Up to 24 weeks
Endometriosis Health Profile-5 (EHP-5)	Every 4 weeks	The EHP-5 assesses quality of life.
Visual Analog Scale (VAS) scores	Every 4 weeks	VAS measures endometriosis pain.
Number of Subjects with Adverse Events	Up to 24 weeks
Clinical Laboratory Tests	Up to 24 weeks
Vital Sign Measurements	Up to 24 weeks
Physical Examinations	Up to 24 weeks

Trial Locations

Locations (15)

Site Reference ID/Investigator# 56269; 🇺🇸 Oak Brook, Illinois, United States

Site Reference ID/Investigator# 55214; 🇺🇸 San Ramon, California, United States

Site Reference ID/Investigator# 56271; 🇺🇸 Peoria, Illinois, United States

Site Reference ID/Investigator# 56268; 🇺🇸 Sandy, Utah, United States

Site Reference ID/Investigator# 56275; 🇺🇸 Spokane, Washington, United States

Site Reference ID/Investigator# 56266; 🇺🇸 Phoenix, Arizona, United States

Site Reference ID/Investigator# 55210; 🇺🇸 San Diego, California, United States

Site Reference ID/Investigator# 56267; 🇺🇸 Clearwater, Florida, United States

Site Reference ID/Investigator# 56273; 🇺🇸 Chicago, Illinois, United States

Site Reference ID/Investigator# 55211; 🇺🇸 Arlington, Texas, United States

Site Reference ID/Investigator# 55212; 🇺🇸 Virginia Beach, Virginia, United States

Site Reference ID/Investigator# 56270; 🇺🇸 Champaign, Illinois, United States

Site Reference ID/Investigator# 56272; 🇺🇸 Louisville, Kentucky, United States

Site Reference ID/Investigator# 55213; 🇺🇸 Winston-Salem, North Carolina, United States

Site Reference ID/Investigator# 56274; 🇺🇸 Richmond, Virginia, United States