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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 24, 2014