Endometriosis Trial: Study of NBI-56418 in Endometriosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00109512
Recruitment Status : Completed
First Posted : April 29, 2005
Last Update Posted : February 22, 2012
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: NBI-56418 (GnRH antagonist) Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of NBI-56418 in Endometriosis
Study Start Date : April 2005
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

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)

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Endometriosis Health Profile-5 (EHP-5) [ Time Frame: Every 4 weeks ]
    The EHP-5 assesses quality of life.

  2. Visual Analog Scale (VAS) scores [ Time Frame: Every 4 weeks ]
    VAS measures endometriosis pain.

  3. Number of Subjects with Adverse Events [ Time Frame: Up to 24 weeks ]
  4. Clinical Laboratory Tests [ Time Frame: Up to 24 weeks ]
  5. Vital Sign Measurements [ Time Frame: Up to 24 weeks ]
  6. Physical Examinations [ Time Frame: Up to 24 weeks ]
  7. Electrocardiogram (ECG) tracings [ Time Frame: Up to 24 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00109512

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

Responsible Party: Sponsor Identifier: NCT00109512     History of Changes
Other Study ID Numbers: NBI-56418-0501
First Posted: April 29, 2005    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012

Keywords provided by Abbott:
pelvic pain
painful periods
painful menstruation
menstrual pain

Additional relevant MeSH terms:
Genital Diseases, Female