Endometriosis Trial: Study of NBI-56418 in Endometriosis

February 21, 2012 updated by: Abbott

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total Composite Pelvic Signs and Symptom Scale (CPSSS) scores
Time Frame: 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.
Every 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Endometriosis Health Profile-5 (EHP-5)
Time Frame: Every 4 weeks
The EHP-5 assesses quality of life.
Every 4 weeks
Visual Analog Scale (VAS) scores
Time Frame: Every 4 weeks
VAS measures endometriosis pain.
Every 4 weeks
Number of Subjects with Adverse Events
Time Frame: Up to 24 weeks
Up to 24 weeks
Clinical Laboratory Tests
Time Frame: Up to 24 weeks
Up to 24 weeks
Vital Sign Measurements
Time Frame: Up to 24 weeks
Up to 24 weeks
Physical Examinations
Time Frame: Up to 24 weeks
Up to 24 weeks
Electrocardiogram (ECG) tracings
Time Frame: Up to 24 weeks
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Laura Williams, MD, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 22, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NBI-56418-0501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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