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Efficacy and Safety Study in Endometriosis With NBI-56418; Placebo and Active Controlled

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00797225
First received: November 21, 2008
Last updated: January 2, 2013
Last verified: January 2013
History of Changes

November 21, 2008
January 2, 2013
November 2008
February 2010   (final data collection date for primary outcome measure)
Pain associated with endometriosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00797225 on ClinicalTrials.gov Archive Site
  • Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Laboratory testing including assessment of bone mineral density [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • patient impression of change [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Quality of life, patient impression of change. Safety measure: Laboratory testing including assessment of bone mineral density [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Efficacy and Safety Study in Endometriosis With NBI-56418; Placebo and Active Controlled
A Phase II, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Efficacy and Safety of NBI-56418 in Subjects With Endometriosis

This study is designed to evaluate the safety and beneficial effects of NBI-56418 compared to placebo and leuprorelin (an approved endometriosis therapy) over a three month period followed by an additional three months of treatment on NBI-56418.
Not Provided
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
  • Drug: NBI-56418 sodium
    NBI-56418 sodium, 150 mg or 250 mg
    Other Name: Elagolix Sodium
  • Drug: Leuprorelin
    Leuprorelin 3.75 mg
    Other Name: Prostap
  • Drug: placebo
    Placebo tablet, placebo injection
  • Experimental: 1
    NBI-56418 sodium or placebo
    Interventions:
    • Drug: NBI-56418 sodium
    • Drug: placebo
  • Experimental: 2
    NBI-56418 sodium or placebo
    Interventions:
    • Drug: NBI-56418 sodium
    • Drug: placebo
  • 3
    Leuprorelin or placebo
    Interventions:
    • Drug: Leuprorelin
    • Drug: placebo
  • Placebo Comparator: 4
    placebo
    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
174
February 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria

  • Be female, aged 18 to 45 years, inclusive
  • Have moderate to severe pelvic pain due to endometriosis
  • Have been surgically (laparoscopy) diagnosed with endometriosis within the last 5 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

  • Received a Gonadotropin-releasing hormone (GnRH) agonist, GnRH antagonist, danazol, or have received any of these agents within 6 months of the start of screening.
  • Received subcutaneous medroxyprogesterone acetate (DMPA-SC) or i.m. medroxyprogesterone acetate (DMPA-IM), or have received either 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
  • Are using systemic steroids on a chronic or regular basis within 3 months
  • Have uterine fibroids or other pelvic lesions ≥3 cm in diameter
  • Have had a hysterectomy or oophorectomy
  • Have pelvic pain that is not caused by endometriosis
  • Have unstable medical condition or chronic disease
  • Have been pregnant within the last 6 months and is currently breast feeding
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Hungary,   Poland,   Romania,   Russian Federation,   Ukraine
 
NCT00797225
NBI-56418-0703, 2007-006474-28
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Laura Williams, MD AbbVie
AbbVie
January 2013

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