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

NCT00619866 | Completed Phase 2 Results FDA Drug

• 1 other identifier: NBI-56418-0702
• Study Type: interventional
• Target: 155
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Endometriosis, Pain

Keywords

bone mineral density; Pelvic Pain; estradiol; NBI-56418

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain at Week 12

  The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day. The monthly mean NRS is the average of the daily values reported during the 4 weeks prior to each visit.

  Baseline and week 12

Secondary Outcomes (25)

• Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain

  Baseline and weeks 4 and 8

• Change From Baseline in the Monthly Peak Numerical Rating Score (NRS) for Endometriosis Pain

  Baseline and Weeks 4, 8, and 12

• Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score

  Baseline and weeks 4, 8, and 12

• Change From Baseline in the Monthly Mean Dysmenorrhea Score

  Baseline and Weeks 4, 8, and 12

• Change From Baseline in the Monthly Mean Total of Dysmenorrhea and Non-menstrual Pelvic Pain Scores

  Baseline and Weeks 4, 8, and 12

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants received placebo tablets once a day 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) QD for 12 weeks.

Drug: placebo

Elagolix 150 mg

EXPERIMENTAL

Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.

Drug: Elagolix

Elagolix 250 mg

EXPERIMENTAL

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

Drug: Elagolix

Interventions

Elagolix DRUG

Elagolix tablets administered orally

Also known as: NBI-56418, Orilissa™

Elagolix 150 mg; Elagolix 250 mg

placebo DRUG

Placebo tablet administered orally

Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

MeSH Terms

Conditions

Endometriosis; Pain; Pelvic Pain

Interventions

elagolix

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2008
• First Posted: February 21, 2008
• Study Start: February 19, 2008
• Primary Completion: April 20, 2009
• Study Completion: August 28, 2009
• Last Updated: September 7, 2018
• Results First Posted: September 7, 2018

Record last verified: 2018-03