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Safety and Efficacy 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:
NCT00437658
First received: February 16, 2007
Last updated: January 2, 2013
Last verified: January 2013
History of Changes
  Purpose

This study is designed to see how a research compound (NBI-56418) works compared to DMPA-SC (also known as depo-provera) in women with endometriosis and to see how both may affect bone mineral density.


Condition Intervention Phase
Endometriosis
 Drug: NBI-56418
Drug: depo-subQ provera 104
 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, Active-controlled Study to Access the Safety and Efficacy of NBI-56418 in Subjects With Endometriosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Bone mineral density [ Time Frame: Before randomization ] [ Designated as safety issue: Yes ]
  • Bone mineral density (%Change from baseline) [ Time Frame: Month 3 ] [ Designated as safety issue: Yes ]
  • Bone mineral density (%Change from baseline) [ Time Frame: Month 6 ] [ Designated as safety issue: Yes ]
  • Bone mineral density (%Change from baseline) [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
  • Bone mineral density (%Change from baseline) [ Time Frame: Month 18 ] [ Designated as safety issue: Yes ]
  • Composite pelvic signs and symptoms score [ Time Frame: monthly ] [ Designated as safety issue: No ]

Enrollment: 252
Study Start Date: November 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: DMPA-SC Drug: depo-subQ provera 104
Depo-subQ provera 104 is indicated for the management of pain associated with endometriosis.
Experimental: NBI-56418 150 mg Drug: NBI-56418
NBI-56418 is a novel GnRH antagonist being studied for the management of pain associated with endometriosis.
Experimental: NBI-56418 75 mg Drug: NBI-56418
NBI-56418 is a novel GnRH antagonist being studied for the management of pain associated with endometriosis.

  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 or laparotomy) diagnosed with endometriosis within the last 7 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:

  • Are currently receiving GnRH agonist, GnRH antagonist, DMPA-SC or DMPA-IM or have received any of these agents within the last 12 months
  • 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 currently smoking more than 20 cigarettes per week
  • Are using systemic steroids on a chronic or regular basis within 3 months
  • Have uterine fibroids or other pelvic lesions ≥5 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 year and is currently breast feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437658

  Show 78 Study Locations
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: NCT00437658     History of Changes
Other Study ID Numbers: NBI-56418-0603
Study First Received: February 16, 2007
Last Updated: January 2, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Medroxyprogesterone
Medroxyprogesterone Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
 Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 23, 2013