An Efficacy and Safety Study of NBI-56418 in Endometriosis
This study has been completed.
Sponsor:
AbbVie (prior sponsor, Abbott)
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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00619866
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Hide Study LocationsLocations
| 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 May 16, 2013