An Efficacy and Safety Study of Elagolix (NBI-56418) in Women With Endometriosis

• Status: Completed
• Trial end date: 2009-08-28
• Target enrollment: 0
• Participant gender: Female

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.

• 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 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 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