Status:
COMPLETED
Efficacy and Safety Study of Elagolix Versus Placebo or Leuprorelin Acetate in Endometriosis
Lead Sponsor:
AbbVie
Conditions:
Endometriosis
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
This study is designed to evaluate the safety and beneficial effects of elagolix (NBI-56418) compared to placebo and leuprorelin (an approved endometriosis therapy) over a three month period followed ...
Detailed Description
The study followed a parallel-group design in which participants were randomized (1:1:1:1) to one of the following treatment groups for the first 12 weeks of dosing: 150 mg elagolix once daily (q.d.);...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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 intramuscular (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
Exclusion
Key Trial Info
Start Date :
November 26 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2010
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT00797225
Start Date
November 26 2008
End Date
February 24 2010
Last Update
September 10 2018
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