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An Efficacy and Safety Study of NBI-56418 in Endometriosis

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ClinicalTrials.gov Identifier: NCT00619866
Recruitment Status : Completed
First Posted : February 21, 2008
Last Update Posted : January 8, 2013
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Brief Summary:
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 or disease Intervention/treatment Phase
Endometriosis, Pain Drug: NBI-56418 Drug: placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Dysmenorrhea Assessments [ Time Frame: Daily assessments over 12 weeks ]
  2. Nonmenstrual pelvic pain assessments [ Time Frame: Daily assessments over 12 weeks ]

Secondary Outcome Measures :
  1. Change in Bone Mineral Density [ Time Frame: Week 12 ]
  2. Change in Bone Mineral Density [ Time Frame: Week 24 ]
  3. Change in Bone Mineral Density [ Time Frame: Week 48 (if needed) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00619866


  Show 50 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Laura Williams, MD AbbVie Laboratories

Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT00619866     History of Changes
Other Study ID Numbers: NBI-56418-0702
First Posted: February 21, 2008    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: January 2013

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
bone mineral density
NBI-56418
estradiol
Endometriosis
Pelvic Pain

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female