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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
  Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-56418 in Subjects With Endometriosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 155
Study Start Date: December 2007
Study Completion Date: August 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
NBI-56418 - 150 mg tablet dose level
 Drug: NBI-56418
150 mg tablet
Experimental: 2
NBI-56418 - 250 mg tablet dose level
 Drug: NBI-56418
250 mg tablet
Placebo Comparator: 3
Placebo to match
 Drug: placebo
placebo tablet to match NBI-56418

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00619866

  Show 50 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Laura Williams, MD AbbVie Laboratories
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00619866     History of Changes
Other Study ID Numbers: NBI-56418-0702
Study First Received: January 24, 2008
Last Updated: January 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
bone mineral density
NBI-56418
estradiol
Endometriosis
Pelvic Pain

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 23, 2013