Efficacy and Safety Study in Endometriosis With NBI-56418; Placebo and Active Controlled

This study has been completed.
Sponsor:
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
  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
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: 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# 54365
Budapest, Hungary, 2380
Site Reference ID/Investigator# 54364
Budapest, Hungary, 2380
Site Reference ID/Investigator# 54363
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# 56464
Bucharest, Romania
Site Reference ID/Investigator# 56284
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# 56458
Kiev, Ukraine
Site Reference ID/Investigator# 56455
Kiev, Ukraine
Site Reference ID/Investigator# 56456
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

ClinicalTrials.gov processed this record on October 21, 2014