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An Efficacy and Safety Study of NBI-56418 in Endometriosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00619866
First received: January 24, 2008
Last updated: January 2, 2013
Last verified: January 2013
History of Changes

January 24, 2008
January 2, 2013
December 2007
April 2009   (final data collection date for primary outcome measure)
  • Dysmenorrhea Assessments [ Time Frame: Daily assessments over 12 weeks ] [ Designated as safety issue: No ]
  • Nonmenstrual pelvic pain assessments [ Time Frame: Daily assessments over 12 weeks ] [ Designated as safety issue: No ]
dysmenorrhea and nonmenstrual pelvic pain assessments [ Time Frame: Daily assessments over 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00619866 on ClinicalTrials.gov Archive Site
  • Change in Bone Mineral Density [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
  • Change in Bone Mineral Density [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
  • Change in Bone Mineral Density [ Time Frame: Week 48 (if needed) ] [ Designated as safety issue: Yes ]
Change in Bone Mineral Density [ Time Frame: Week 12, Week 24, and Week 48 (if needed) ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
An Efficacy and Safety Study of NBI-56418 in Endometriosis
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-56418 in Subjects With Endometriosis

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.

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 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 for 12 weeks in a double-blind fashion. The effect of NBI-56418 treatment on bone mineral density (BMD) following 6 months of treatment with NBI-56418.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Endometriosis, Pain
  • Drug: NBI-56418
    150 mg tablet
  • Drug: NBI-56418
    250 mg tablet
  • Drug: placebo
    placebo tablet to match NBI-56418
  • Experimental: 1
    NBI-56418 - 150 mg tablet dose level
    Intervention: Drug: NBI-56418
  • Experimental: 2
    NBI-56418 - 250 mg tablet dose level
    Intervention: Drug: NBI-56418
  • Placebo Comparator: 3
    Placebo to match
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
155
August 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria

  • Be female, aged 18 to 49 years, inclusive
  • Have moderate to severe pelvic pain due to endometriosis
  • Have been surgically (laparoscopy) diagnosed with endometriosis within the last 8 years and have recurrent or persistent endometriosis symptoms
  • Have regular menstrual cycle
  • 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 or GnRH antagonist 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
Female
18 Years to 49 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00619866
NBI-56418-0702
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Laura Williams, MD AbbVie Laboratories
AbbVie
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP