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Endometriosis Trial: Study of NBI-56418 in Endometriosis
This study has been completed.

First Received on April 28, 2005.   Last Updated on March 20, 2008   History of Changes
Sponsor: Neurocrine Biosciences
Information provided by: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT00109512
  Purpose

Seventy-two subjects will be randomized to one of three treatment groups: placebo (capsules that will look like the study drug), 75 mg and 150 mg NBI-56418 in a 1:1:1 ratio. Study drug will be administered once daily for 12 weeks. After the last dose at the end of Week 12, follow-up will continue every 4 weeks for 12 weeks.


Condition Intervention Phase
Endometriosis
Drug: NBI-56418 (GnRH antagonist)
Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of NBI-56418 in Endometriosis

Resource links provided by NLM:


Further study details as provided by Neurocrine Biosciences:

Estimated Enrollment: 72
Study Start Date: April 2005
Study Completion Date: June 2006
  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109512

Locations
United States, Arizona
Arizona Wellness Center for Women
Phoenix, Arizona, United States, 85032
United States, California
Genesis Center for Clinical Research
San Diego, California, United States, 92103
Reproductive Science Center of the SF Bay Area
San Ramon, California, United States, 94583
United States, Florida
Women's Medical Research Group, LLC
Clearwater, Florida, United States, 33759
United States, Illinois
Women's Health Practice
Champaign, Illinois, United States, 61820
Center for Women's Research
Chicago, Illinois, United States, 60612
Institute for the Study and Treatment of Endometriosis
Oak Brook, Illinois, United States, 60523
Falcon Center for Women
Peoria, Illinois, United States, 61615
United States, Kentucky
Bluegrass Clinical Research, Inc.
Louisville, Kentucky, United States, 40291
United States, North Carolina
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, United States, 27103
United States, Texas
Medical Clinic of N. Texas
Arlington, Texas, United States, 76012
United States, Utah
Salt Lake Womens' Center
Sandy, Utah, United States, 84070
United States, Virginia
Tidewater Clinical Research
Norfolk, Virginia, United States, 23502
National Clinical Research, Inc.
Richmond, Virginia, United States, 23294
United States, Washington
Northwest OB/GYN
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Neurocrine Biosciences
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00109512     History of Changes
Other Study ID Numbers: NBI-56418-0501
Study First Received: April 28, 2005
Last Updated: March 20, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Neurocrine Biosciences:
endometriosis
pelvic pain
painful periods
dysmenorrhea
painful menstruation
GnRH
agonist
antagonist
menstrual pain

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on February 09, 2012