Efficacy and Safety Study of Elagolix in Women With Endometriosis

NCT ID: NCT00973973

Last Updated: 2018-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-12
• Study Completion Date: 2010-09-22

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 additional 16 weeks in an open-label phase where all participants still enrolled in the study received 150 mg elagolix once daily.

There was no pre-specified primary efficacy end point for this study as there is no single key efficacy outcome measure in this exploratory Phase 2 study. However, the efficacy measures of primary interest included the daily assessment of dysmenorrhea, non-menstrual pelvic pain and dyspareunia on a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) using an e-Diary.

Conditions

Endometriosis, Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Elagolix 150 mg

Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.

Group Type: EXPERIMENTAL

Elagolix

Intervention Type: DRUG

Immediate release (IR) tablets taken orally once a day

Placebo

Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo tablets taken orally once a day

Elagolix

Intervention Type: DRUG

Immediate release (IR) tablets taken orally once a day

Interventions

Placebo

Matching placebo tablets taken orally once a day

Intervention Type: DRUG

Elagolix

Immediate release (IR) tablets taken orally once a day

Intervention Type: DRUG

Other Intervention Names

NBI-56418; Orilissa™

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Other Identifiers

NBI-56418-0901

Identifier Type: -

Identifier Source: org_study_id