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

  Hide Study Locations
Locations
United States, Alabama
Site Reference ID/Investigator# 58185
Dothan, Alabama, United States, 36303
Site Reference ID/Investigator# 58194
Huntsville, Alabama, United States, 35801
United States, Arizona
Site Reference ID/Investigator# 57988
Phoenix, Arizona, United States, 85015
United States, Arkansas
Site Reference ID/Investigator# 57991
Little Rock, Arkansas, United States, 72205
United States, California
Site Reference ID/Investigator# 58187
Encinitas, California, United States, 92024
Site Reference ID/Investigator# 57989
San Diego, California, United States, 92108
Site Reference ID/Investigator# 58166
Vallejo, California, United States, 94589
United States, Colorado
Site Reference ID/Investigator# 58182
Denver, Colorado, United States, 80220
United States, Connecticut
Site Reference ID/Investigator# 58002
Milford, Connecticut, United States, 06460
Site Reference ID/Investigator# 58186
Waterbury, Connecticut, United States, 06708
United States, Florida
Site Reference ID/Investigator# 57980
Boynton Beach, Florida, United States, 33472
Site Reference ID/Investigator# 58005
Clearwater, Florida, United States, 33759
Site Reference ID/Investigator# 58189
Jacksonville, Florida, United States, 32216
Site Reference ID/Investigator# 58007
Tampa, Florida, United States, 33613
Site Reference ID/Investigator# 57998
West Palm Beach, Florida, United States, 33409-3509
United States, Illinois
Site Reference ID/Investigator# 57985
Oak Brook, Illinois, United States, 60523
United States, Indiana
Site Reference ID/Investigator# 57981
South Bend, Indiana, United States, 46601
United States, Kansas
Site Reference ID/Investigator# 58003
Wichita, Kansas, United States, 67208
United States, Kentucky
Site Reference ID/Investigator# 57986
Louisville, Kentucky, United States, 40291
United States, Maryland
Site Reference ID/Investigator# 57997
Baltimore, Maryland, United States, 21229
United States, Michigan
Site Reference ID/Investigator# 57984
Detroit, Michigan, United States, 48201
United States, New Jersey
Site Reference ID/Investigator# 58163
Plainsboro, New Jersey, United States, 08536
United States, North Carolina
Site Reference ID/Investigator# 58191
Charlotte, North Carolina, United States, 28209
Site Reference ID/Investigator# 57993
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Site Reference ID/Investigator# 57999
Cincinnati, Ohio, United States, 45267
Site Reference ID/Investigator# 57995
Columbus, Ohio, United States, 43213
Site Reference ID/Investigator# 58183
Dayton, Ohio, United States, 45408
Site Reference ID/Investigator# 58006
Englewood, Ohio, United States, 45322
United States, Oklahoma
Site Reference ID/Investigator# 58004
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Site Reference ID/Investigator# 58000
Medford, Oregon, United States, 97504
Site Reference ID/Investigator# 57992
Portland, Oregon, United States, 97239
United States, Pennsylvania
Site Reference ID/Investigator# 58184
Pittsburgh, Pennsylvania, United States, 15206
United States, South Carolina
Site Reference ID/Investigator# 58193
Gaffney, South Carolina, United States, 29340
Site Reference ID/Investigator# 57987
Greenville, South Carolina, United States, 29615
United States, Tennessee
Site Reference ID/Investigator# 58165
Chattanooga, Tennessee, United States, 37404
Site Reference ID/Investigator# 57982
Nashville, Tennessee, United States, 37203
United States, Texas
Site Reference ID/Investigator# 58192
Austin, Texas, United States, 78737
Site Reference ID/Investigator# 58168
Austin, Texas, United States, 78705
Site Reference ID/Investigator# 57983
Dallas, Texas, United States, 75390-8852
Site Reference ID/Investigator# 57994
Houston, Texas, United States, 77030
Site Reference ID/Investigator# 58190
Houston, Texas, United States, 77030
Site Reference ID/Investigator# 58164
San Antonio, Texas, United States, 78229
Site Reference ID/Investigator# 58162
Schertz, Texas, United States, 78154
United States, Utah
Site Reference ID/Investigator# 58167
Pleasant Grove, Utah, United States, 84062
Site Reference ID/Investigator# 58001
Sandy, Utah, United States, 84070
United States, Vermont
Site Reference ID/Investigator# 58188
Burlington, Vermont, United States, 05405
United States, Virginia
Site Reference ID/Investigator# 57996
Richmond, Virginia, United States, 23225
Site Reference ID/Investigator# 58169
Richmond, Virginia, United States, 23233
United States, Washington
Site Reference ID/Investigator# 57990
Seattle, Washington, United States, 98105
United States, Wisconsin
Site Reference ID/Investigator# 57979
LaCrosse, Wisconsin, United States, 54601
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 July 20, 2014