Status:
COMPLETED
Efficacy and Safety Study of Elagolix in Women With Endometriosis
Lead Sponsor:
AbbVie
Conditions:
Endometriosis, Pain
Eligibility:
FEMALE
18-49 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate elagolix (NBI-56418) compared to placebo for its effects on endometriosis related pelvic pain and its safety.
Detailed Description
Participants were randomized (1:1) to 150 mg elagolix once daily or placebo once daily for the first 8 weeks of the study. Following 8 weeks of dosing, participants continued in the study for an addit...
Eligibility Criteria
Inclusion
- Be female, aged 18 to 49 years, inclusive.
- Have moderate to severe pelvic pain due to endometriosis.
- Have a history of regular menstrual cycles.
- Have been surgically (laparoscopy or laparotomy) diagnosed with endometriosis within 8 years of the start of screening.
- 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, a GnRH antagonist other than NBI-56418, or danazol 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 :
October 12 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2010
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT00973973
Start Date
October 12 2009
End Date
September 22 2010
Last Update
September 26 2018
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