Safety and Efficacy Study of NBI-56418 in Endometriosis

Verified by: Neurocrine Biosciences, September 2009
First Received: February 16, 2007 | Last Updated: September 28, 2009 | Phase: Phase 2 | Start Date: November 2006
Overall Status: Completed | Estimated Enrollment: 240
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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...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: November 2008

Intervention(s) in this Clinical Trial

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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Neurocrine Biosciences Industry

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

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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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00437658