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Endometriosis Trial: Study of NBI-56418 in Endometriosis


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  • Purpose

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    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.


    status: completed
    conditions: Endometriosis
    interventions: NBI-56418 (GnRH antagonist)
    phase: Phase 2
    study type: Interventional
    study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
    official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of NBI-56418 in Endometriosis

  • Further study details (as provided by Neurocrine Biosciences)

    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

    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

    facility: Phoenix, Arizona, United States, 85032

    United States , California  - Genesis Center for Clinical Research

    facility: San Diego, California, United States, 92103

    United States , California  - Reproductive Science Center of the SF Bay Area

    facility: San Ramon, California, United States, 94583

    United States , Florida  - Women's Medical Research Group, LLC

    facility: Clearwater, Florida, United States, 33759

    United States , Illinois  - Institute for the Study and Treatment of Endometriosis

    facility: Oak Brook, Illinois, United States, 60523

    United States , Illinois  - Women's Health Practice

    facility: Champaign, Illinois, United States, 61820

    United States , Illinois  - Falcon Center for Women

    facility: Peoria, Illinois, United States, 61615

    United States , Illinois  - Center for Women's Research

    facility: Chicago, Illinois, United States, 60612

    United States , Kentucky  - Bluegrass Clinical Research, Inc.

    facility: Louisville, Kentucky, United States, 40291

    United States , North Carolina  - Lyndhurst Gynecologic Associates

    facility: Winston-Salem, North Carolina, United States, 27103

    United States , Texas  - Medical Clinic of N. Texas

    facility: Arlington, Texas, United States, 76012

    United States , Utah  - Salt Lake Womens' Center

    facility: Sandy, Utah, United States, 84070

    United States , Virginia  - Tidewater Clinical Research

    facility: Norfolk, Virginia, United States, 23502

    United States , Virginia  - National Clinical Research, Inc.

    facility: Richmond, Virginia, United States, 23294

    United States , Washington  - Northwest OB/GYN

    facility: Spokane, Washington, United States, 99204

  • Sponsors and collaborators

    Neurocrine Biosciences

  • More information

    Click here to find out more about the study sponsor, Neurocrine Biosciences

    first received: April 28, 2005
    last updated: March 20, 2008
    ClinicalTrials.gov Identifier: NCT00109512
    health authority: United States: Food and Drug Administration

Information obtained from ClinicalTrials.gov on September 25, 2009   Link to the current ClinicalTrials.gov record.

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