Efficacy and Safety Study of Elagolix Versus Placebo or Leuprorelin Acetate in Endometriosis

• Status: Completed
• Trial end date: 2010-02-24
• Target enrollment: 0
• Participant gender: Female

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 by an additional three months of treatment on elagolix.

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

Details

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

Criteria

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