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Sponsored by: |
Neurocrine Biosciences |
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Information provided by: | Neurocrine Biosciences |
ClinicalTrials.gov Identifier: | NCT00619866 |
This study is designed to see how a research compound (NBI- 56418) works compared to placebo (also known as a sugar pill) in women with endometriosis and to see the effect, if any, on bone mineral density.
Condition | Intervention | Phase |
---|---|---|
Endometriosis Pain |
Drug: NBI-56418 Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-56418 in Subjects With Endometriosis |
Estimated Enrollment: | 150 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
NBI-56418 - 150 mg tablet dose level
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Drug: NBI-56418
150 mg tablet
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2: Experimental
NBI-56418 - 250 mg tablet dose level
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Drug: NBI-56418
250 mg tablet
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3: Placebo Comparator
Placebo to match
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Drug: placebo
placebo tablet to match NBI-56418
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This is a Phase II, multicenter, randomized, double-blind, placebo-controlled parallel-group study to assess the efficacy and safety of NBI-56418 at two dose levels (150 mg and 250 mg) administered once daily for up to 6 months. Approximately 150 subjects will be randomized (1:1:1) to one of the following treatment groups for the first 12 weeks of dosing: 150 mg NBI-56418 q.d.; 250 mg NBI-56418 q.d; or placebo q.d. Following 12 weeks of dosing, subjects will continue in the study for an additional 12 weeks; subjects randomized to NBI-56418 will continue to receive their assigned dose and subjects randomized to placebo will be re-randomized to receive one of the two doses of NBI-56418 (150 mg or 250 mg) for 12 weeks in a double-blind fashion. Blinding will be achieved using a double-dummy design. 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). Subjects whose BMD, as measured by dual energy X-ray absorptiometry (DXA), at the end of Week 24 has decreased more than 3% from screening will be required to have an additional DXA scan at 6 months posttreatment.
Ages Eligible for Study: | 18 Years to 49 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Neurocrine Biosciences ( Robert Imani, MD, PhD/Medical Director ) |
Study ID Numbers: | NBI-56418-0702 |
Study First Received: | January 24, 2008 |
Last Updated: | October 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00619866 |
Health Authority: | United States: Food and Drug Administration |
endometriosis pelvic pain NBI-56418 bone mineral density estradiol |
Genital Diseases, Female Pelvic Pain Estradiol 3-benzoate Estradiol valerate Endometriosis |
Pain Estradiol 17 beta-cypionate Polyestradiol phosphate Estradiol |