Official Title: “A Phase II, Randomized, Double-Blind, Randomized, Active-Controlled Study to Assess the Safety and Efficacy of NBI-56418 in Subjects With Endometriosis”

This study is designed to see how a research compound (NBI-56418) works compared to DMPA-SC (also known as depo-provera) in women with endometriosis and to see how both may affect bone mineral density.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: NBI-56418
• Drug: depo-subQ provera 104

Primary Measures

• Bone mineral density
  • Time Frame: Screening, 3 mo., 6 mo., 12 mo., 18 mo.
    
• Composite pelvic signs and symptoms score
  • Time Frame: monthly
    

Inclusion Criteria:

• Be female, aged 18 to 49 years, inclusive
• Have moderate to severe pelvic pain due to endometriosis
• Have been surgically (laparoscopy or laparotomy) diagnosed with endometriosis within the last 7 years and have recurrent or persistent endometriosis symptoms
• Have regular menstrual cycle (23-33 day)
• Agree to use two forms of non-hormonal contraception during the study

Exclusion Criteria:

• Are currently receiving GnRH agonist, GnRH antagonist, DMPA-SC or DMPA-IM or have received any of these agents within the last 12 months
• Are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within the last month
• Have had surgery for endometriosis within the last month
• Are currently smoking more than 20 cigarettes per week
• Are using systemic steroids on a chronic or regular basis within 3 months
• Have uterine fibroids or other pelvic lesions ≥5 cm in diameter
• Have pelvic pain that is not caused by endometriosis
• Have unstable medical condition or chronic disease
• Have been pregnant within the last year and is currently breast feeding

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 49 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Neurocrine Biosciences

Information obtained from ClinicalTrials.gov on October 15, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00437658

Study ID Number: NBI-56418-0603

ClinicalTrials.gov Identifier: NCT00437658

Health Authority: United States: Food and Drug Administration

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