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Efficacy and Safety Study of NBI-56418 Na in Subjects With Endometriosis - NCT00973973-(Clinical Trial 319978)



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City:  LaCrosse
State:  
WI
Zip Code:
Conditions: Endometriosis - Pain
Purpose: The purpose of this study is to evaluate NBI-56418 compared to placebo (also known as a sugar pill) for its effects on endometriosis related pelvic pain and its safety.
Study summary: This is a Phase 2, multicenter, randomized, double-blind, placebo controlled parallel group study to assess the efficacy and safety of 150 mg NBI-56418 Na (also referred to in this document as NBI-56418) administered once daily (q.d.) for up to 24 weeks. Approximately 120 subjects will be randomized (1:1) to 150 mg NBI-56418 q.d. or placebo q.d. for the first 8 weeks of dosing. Following 8 weeks of dosing, subjects will continue in the study for an additional 16 weeks in an open-label phase where all subjects still enrolled in the study will receive 150 mg NBI-56418 q.d. Six weeks after the last dose of study drug at the end of Week 24, a follow-up visit will be performed (end of Week 30).
Criteria: Inclusion Criteria: - Be female, aged 18 to 49 years, inclusive. - Have moderate to severe pelvic pain due to endometriosis. - Have a history of regular menstrual cycles. - Have been surgically (laparoscopy or laparotomy) diagnosed with endometriosis within 8 years of the start of screening. - Have a Body Mass Index (BMI) of 18 to 36 kg/m2, inclusive. - Agree to use two forms of non-hormonal contraception during the study. Exclusion Criteria: - Are currently receiving GnRH agonist, a GnRH antagonist other than NBI-56418, or danazol or have received any of these agents within 6 months of the start of screening. - Are currently receiving DMPA-SC or DMPA-IM or have received any of these agents within 3 months of the start of screening. - 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. - Have had a hysterectomy or bilateral oophorectomy. - Are using systemic steroids on a chronic or regular basis within 3 months. - Have uterine fibroids ≥3 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 six months. - Currently breast feeding.
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Data Source: ClinicalTrials.gov
Date Processed: January 20, 2010
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