Safety and Efficacy Study of NBI-56418 in Endometriosis - Tabular View

Tracking Information
First Received Date ^ICMJE	February 16, 2007
Last Updated Date	September 28, 2009
Start Date ^ICMJE	November 2006
Primary Completion Date	November 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 5, 2007)	Bone mineral density [ Time Frame: Screening, 3 mo., 6 mo., 12 mo., 18 mo. ] Composite pelvic signs and symptoms score [ Time Frame: monthly ]
Original Primary Outcome Measures ^ICMJE (submitted: February 16, 2007)	Bone mineral density Composite pelvic signs and symptoms score
Change History	Complete list of historical versions of study NCT00437658 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Study of NBI-56418 in Endometriosis
Official Title ^ICMJE	A Phase II, Randomized, Double-Blind, Randomized, Active-Controlled Study to Assess the Safety and Efficacy of NBI-56418 in Subjects With Endometriosis
Brief Summary	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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Endometriosis
Intervention ^ICMJE	Drug: NBI-56418 Drug: depo-subQ provera 104
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	240
Completion Date	May 2009
Primary Completion Date	November 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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	Female
Ages	18 Years to 49 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00437658
Responsible Party
Study ID Numbers ^ICMJE	NBI-56418-0603
Study Sponsor ^ICMJE	Neurocrine Biosciences
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Neurocrine Biosciences
Verification Date	September 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP