Efficacy and Safety Study in Endometriosis With NBI-56418; Placebo and Active Controlled
This study has been completed.
Sponsor:
AbbVie (prior sponsor, Abbott)
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometriosis |
Drug: NBI-56418 sodium Drug: Leuprorelin 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- and Active-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:
- Pain associated with endometriosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 174 |
| Study Start Date: | November 2008 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
NBI-56418 sodium or placebo
|
Drug: NBI-56418 sodium
NBI-56418 sodium, 150 mg or 250 mg
Other Name: Elagolix Sodium
Drug: placebo
Placebo tablet, placebo injection
|
|
Experimental: 2
NBI-56418 sodium or placebo
|
Drug: NBI-56418 sodium
NBI-56418 sodium, 150 mg or 250 mg
Other Name: Elagolix Sodium
Drug: placebo
Placebo tablet, placebo injection
|
|
3
Leuprorelin or placebo
|
Drug: Leuprorelin
Leuprorelin 3.75 mg
Other Name: Prostap
Drug: placebo
Placebo tablet, placebo injection
|
|
Placebo Comparator: 4
placebo
|
Drug: placebo
Placebo tablet, placebo injection
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00797225
Locations
| Bulgaria | |
| Site Reference ID/Investigator# 54366 | |
| Sofia, Bulgaria | |
| Site Reference ID/Investigator# 54367 | |
| Sofia, Bulgaria | |
| Site Reference ID/Investigator# 56276 | |
| Sofia, Bulgaria | |
| Hungary | |
| Site Reference ID/Investigator# 54364 | |
| Budapest, Hungary, 2380 | |
| Site Reference ID/Investigator# 54363 | |
| Budapest, Hungary, 2380 | |
| Site Reference ID/Investigator# 54365 | |
| Budapest, Hungary, 2380 | |
| Site Reference ID/Investigator# 54362 | |
| Debrecen, Hungary, 4029 | |
| Site Reference ID/Investigator# 56463 | |
| Gyor, Hungary | |
| Site Reference ID/Investigator# 56462 | |
| Karcag, Hungary | |
| Poland | |
| Site Reference ID/Investigator# 56280 | |
| Bialystok, Poland | |
| Site Reference ID/Investigator# 56278 | |
| Katowice, Poland | |
| Site Reference ID/Investigator# 56277 | |
| Krakow, Poland | |
| Site Reference ID/Investigator# 56282 | |
| Poznan, Poland | |
| Site Reference ID/Investigator# 56281 | |
| Szczecin, Poland | |
| Site Reference ID/Investigator# 56279 | |
| Warsaw, Poland | |
| Romania | |
| Site Reference ID/Investigator# 56461 | |
| Brasov, Romania | |
| Site Reference ID/Investigator# 56284 | |
| Bucharest, Romania | |
| Site Reference ID/Investigator# 56464 | |
| Bucharest, Romania | |
| Site Reference ID/Investigator# 56460 | |
| Cluj-Napoca, Romania | |
| Site Reference ID/Investigator# 56465 | |
| Oradea, Romania | |
| Site Reference ID/Investigator# 56283 | |
| Targu Mures, Romania | |
| Site Reference ID/Investigator# 56459 | |
| Timisoara, Romania | |
| Russian Federation | |
| Site Reference ID/Investigator# 56285 | |
| St. Petersburg, Russian Federation | |
| Ukraine | |
| Site Reference ID/Investigator# 56456 | |
| Kiev, Ukraine | |
| Site Reference ID/Investigator# 56455 | |
| Kiev, Ukraine | |
| Site Reference ID/Investigator# 56458 | |
| Kiev, Ukraine | |
| Site Reference ID/Investigator# 56457 | |
| Vinnitsa, Ukraine | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
| Study Director: | Laura Williams, MD | AbbVie |
More Information
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT00797225 History of Changes |
| Other Study ID Numbers: | NBI-56418-0703, 2007-006474-28 |
| Study First Received: | November 21, 2008 |
| Last Updated: | January 2, 2013 |
| Health Authority: | United States: Food and Drug Administration Hungary: National Institute of Pharmacy Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: Ministry of Public Health Romania: National Medicines Agency Russia: Ministry of Health of the Russian Federation Ukraine: Ministry of Health |
Keywords provided by AbbVie:
|
bone mineral density Endometriosis Pelvic Pain |
Additional relevant MeSH terms:
|
Endometriosis Genital Diseases, Female Leuprolide Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Fertility Agents, Female Fertility Agents Reproductive Control Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013