Status:
COMPLETED
An Efficacy and Safety Study of Elagolix (NBI-56418) in Women With Endometriosis
Lead Sponsor:
AbbVie
Conditions:
Endometriosis, Pain
Eligibility:
FEMALE
18-49 years
Phase:
PHASE2
Brief Summary
This study is designed to see how elagolix works compared to placebo in women with endometriosis and to see the effect, if any, on bone mineral density.
Detailed Description
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled parallel-group study to assess the efficacy and safety of elagolix at two dose levels administered once daily for up to 6 ...
Eligibility Criteria
Inclusion
- 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
- Are currently receiving gonadotropin-releasing hormone (GnRH) agonist or GnRH antagonist or have received any of these agents within 6 months of the start of screening
- Are currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or intramuscular medroxyprogesterone acetate (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
Key Trial Info
Start Date :
February 19 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2009
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT00619866
Start Date
February 19 2008
End Date
August 28 2009
Last Update
September 7 2018
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