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

NCT ID: NCT00797225

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-26
• Study Completion Date: 2010-02-24

Brief 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.

Detailed Description

The study followed a parallel-group design in which participants were randomized (1:1:1:1) to one of the following treatment groups for the first 12 weeks of dosing: 150 mg elagolix once daily (q.d.); 250 mg elagolix q.d.; placebo; or leuprorelin acetate depot injection 3.75 mg (monthly). Blinding was achieved using a double-dummy design. Following 12 weeks of dosing, participants continued in the study for an additional 12 weeks; participants randomized to elagolix continued to receive their assigned dose and participants randomized to placebo or leuprorelin acetate were re-randomized to receive one of the two doses of elagolix (150 mg q.d. or 250 mg q.d.) for 12 weeks in a double-blind fashion. Six weeks after the last dose of the study drug at the end of Week 24, a follow-up visit was performed (end of Week 30).

There was no pre-specified primary efficacy end point as there was no single key efficacy outcome measure in this exploratory Phase 2 study. For purposes of results reported here, Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain is designated as the primary outcome measure.

Conditions

Endometriosis

Study Design

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

Study Groups

Placebo

Participants received placebo tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo to Elagolix

Intervention Type: DRUG

Placebo tablet administered orally

Placebo to Leuprorelin Acetate

Intervention Type: DRUG

Saline solution administered as an intramuscular injection

Elagolix 150 mg

Participants received elagolix 150 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg for an additional 12 weeks.

Group Type: EXPERIMENTAL

Elagolix

Intervention Type: DRUG

Elagolix tablets administered orally

Placebo to Leuprorelin Acetate

Intervention Type: DRUG

Saline solution administered as an intramuscular injection

Elagolix 250 mg

Participants received elagolix 250 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.

Group Type: EXPERIMENTAL

Elagolix

Intervention Type: DRUG

Elagolix tablets administered orally

Placebo to Leuprorelin Acetate

Intervention Type: DRUG

Saline solution administered as an intramuscular injection

Leuprorelin

Participants received placebo tablets once a day and leuprorelin acetate 1-month depot 3.75 mg intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) for 12 weeks.

Group Type: OTHER

Leuprorelin Acetate Depot

Intervention Type: DRUG

Leuprorelin acetate depot injection 3.75 mg administered as an intramuscular injection

Placebo to Elagolix

Intervention Type: DRUG

Placebo tablet administered orally

Interventions

Leuprorelin Acetate Depot

Leuprorelin acetate depot injection 3.75 mg administered as an intramuscular injection

Intervention Type: DRUG

Elagolix

Elagolix tablets administered orally

Intervention Type: DRUG

Placebo to Elagolix

Placebo tablet administered orally

Intervention Type: DRUG

Placebo to Leuprorelin Acetate

Saline solution administered as an intramuscular injection

Intervention Type: DRUG

Other Intervention Names

Prostap SR; NBI-56418; Orilissa™

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 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

2007-006474-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NBI-56418-0703

Identifier Type: -

Identifier Source: org_study_id