Endometriosis Trial: Study of NBI-56418 in Endometriosis

A Phase II, Randomized, Double-Blind, Placebo-Controlled 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, follow-up continued every 4 weeks for 12 weeks.

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Drug: placebo; Drug: NBI-56418 (GnRH antagonist)

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Site Reference ID/Investigator# 56266
  • California
    • San Diego, California, United States, 92103
      • Site Reference ID/Investigator# 55210
    • San Ramon, California, United States, 94566
      • Site Reference ID/Investigator# 55214
  • Florida
    • Clearwater, Florida, United States, 33759
      • Site Reference ID/Investigator# 56267
  • Illinois
    • Champaign, Illinois, United States, 61820
      • Site Reference ID/Investigator# 56270
    • Chicago, Illinois, United States, 60612
      • Site Reference ID/Investigator# 56273
    • Oak Brook, Illinois, United States, 60523
      • Site Reference ID/Investigator# 56269
    • Peoria, Illinois, United States, 61615
      • Site Reference ID/Investigator# 56271
  • Kentucky
    • Louisville, Kentucky, United States, 40291
      • Site Reference ID/Investigator# 56272
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Site Reference ID/Investigator# 55213
  • Texas
    • Arlington, Texas, United States, 76012
      • Site Reference ID/Investigator# 55211
  • Utah
    • Sandy, Utah, United States, 84070
      • Site Reference ID/Investigator# 56268
  • Virginia
    • Richmond, Virginia, United States, 23294
      • Site Reference ID/Investigator# 56274
    • Virginia Beach, Virginia, United States, 23451
      • Site Reference ID/Investigator# 55212
  • Washington
    • Spokane, Washington, United States, 99204
      • Site Reference ID/Investigator# 56275

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria

• Be female, aged 18 to 49 years, inclusive.
• Have pelvic pain and dysmenorrhea resulting in a Composite Pelvic Sign and Symptoms Score (CPSSS) of ≥ 6.
• Have had a diagnosis of endometriosis made following laparoscopic visualization of the disease within the last 5 years of the start of screening.
• Have regular menstrual cycles (28 days ±5 days) for greater than or equal to 2 years. For the cycle that immediately precedes dosing, cycle length will be determined as part of the medical history.
• Have a Body Mass Index between 18 and 30 kg/m2.
• Agree to use two forms of non-hormonal contraception (unless sterilized by tubal ligation) for greater than or equal to 3 months prior to Screening through ovulation and return of menses after treatment.
• Have a negative serum pregnancy test at Screening and a negative urine pregnancy test at prior to dosing at the beginning of Week 1.
• Have a cervical smear negative for malignancy at Screening.
• Be willing to comply with all study procedures and restrictions.
• Be able to read, understand, and sign the ICF (informed consent form) before entering into the study.
• Be willing to provide authorization for access to personal health information in conjunction with US Health Insurance Portability and Accountability Act (HIPAA).

Exclusion Criteria

• Are currently receiving a GnRH agonist or GnRH antagonist, or have received any of these agents within 6 months of Screening.
• Have been nonresponsive to GnRH agonist or antagonist therapy for the management of endometriosis.
• Are currently receiving hormonal therapy including the oral contraceptive pill or have received any of these agents within 3 months of Screening.
• Are on any concurrent medical treatment/medications or have had surgical or hormonal treatment other than oral contraceptives for endometriosis within 3 months of Screening.
• Have uterine fibroids or any other pelvic lesions greater than or equal to 3 cm in diameter as verified by ultrasound.
• Are currently breast-feeding an infant.
• Are using any steroid preparation, taken by any route (e.g., oral, inhaled) on a chronic or regular basis within 3 months of Screening.
• Have an unstable medical condition or chronic disease (including history of neurological [including cognitive], hepatic, renal, cardiovascular, gastrointestinal, pulmonary, or endocrine disease), or malignancy that could confound interpretation of the study outcomes.
• Have chronic pelvic pain that is not caused by endometriosis.
• Have any psychological disorder according to criteria indicated in the Diagnostics and Statistical Manual of Mental Disorders, 4th edition within one year before screening. Such disorders include, but are not limited to, alcohol and substance abuse/dependence.
• Have a history of poor compliance in clinical research studies.
• Have a medically significant illness in the 30 days before the beginning of Week 1.
• Have a medically significant abnormality observed upon Screening or the beginning of Week 1 physical examination, or in any other baseline measurement. Findings outside the standard reference ranges will be jointly approved with NBI's (Neurocrine Biosciences) Medical Monitor before being considered eligible for the study.
• Are using any investigational drug within 2 months of Screening.
• Have a positive human immunodeficiency virus antibody (HIV Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCV-Ab) assay at Screening or have a history of a positive result.
• Have an allergy, hypersensitivity, or intolerance to a GnRH agonist or antagonist.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: placebo
Experimental: NBI-56418 75 mg	Drug: NBI-56418 (GnRH antagonist)
Experimental: NBI-56418 150 mg	Drug: NBI-56418 (GnRH antagonist)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endometriosis Health Profile-5 (EHP-5)	The EHP-5 assesses quality of life.	Every 4 weeks
Visual Analog Scale (VAS) scores	VAS measures endometriosis pain.	Every 4 weeks
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
Electrocardiogram (ECG) tracings		Up to 24 weeks

Collaborators and Investigators

• Sponsor: Abbott
• Investigators: Study Director: Laura Williams, MD, Abbott

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion (Actual): June 1, 2006
• Study Completion (Actual): June 1, 2006

Study Registration Dates

• First Submitted: April 28, 2005
• First Submitted That Met QC Criteria: April 28, 2005
• First Posted (Estimate): April 29, 2005

Study Record Updates

• Last Update Posted (Estimate): February 22, 2012
• Last Update Submitted That Met QC Criteria: February 21, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: endometriosis; agonist; antagonist; GnRH; dysmenorrhea; pelvic pain; menstrual pain; painful menstruation; painful periods
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: NBI-56418-0501