Efficacy and Safety Study of Elagolix in Women With Endometriosis

• Status: Completed
• Trial end date: 2010-09-22
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie; AbbVie (prior sponsor, Abbott)

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.