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

NCT00797225 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: NBI-56418-07032007-006474-28
• Study Type: interventional
• Target: 174
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endometriosis

Keywords

bone mineral density,endometriosis,pelvic pain

Outcome Measures

Primary Outcomes (1)

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

  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 Weeks 4, 8, and 12

Secondary Outcomes (23)

• 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 Sum of Dysmenorrhea and Non-menstrual Pelvic Pain Scores

  Baseline and Weeks 4, 8, and 12

• Change From Baseline in the Percentage of Days of Any Analgesic Use

  Baseline, Weeks 4, 8 and 12

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo to Elagolix; Drug: Placebo to Leuprorelin Acetate

Elagolix 150 mg

EXPERIMENTAL

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.

Drug: Elagolix; Drug: Placebo to Leuprorelin Acetate

Elagolix 250 mg

EXPERIMENTAL

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.

Drug: Elagolix; Drug: Placebo to Leuprorelin Acetate

Leuprorelin

OTHER

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.

Drug: Leuprorelin Acetate Depot; Drug: Placebo to Elagolix

Interventions

Leuprorelin Acetate Depot DRUG

Leuprorelin acetate depot injection 3.75 mg administered as an intramuscular injection

Also known as: Prostap SR

Leuprorelin

Elagolix DRUG

Elagolix tablets administered orally

Also known as: NBI-56418, Orilissa™

Elagolix 150 mg; Elagolix 250 mg

Placebo to Elagolix DRUG

Placebo tablet administered orally

Leuprorelin; Placebo

Placebo to Leuprorelin Acetate DRUG

Saline solution administered as an intramuscular injection

Elagolix 150 mg; Elagolix 250 mg; Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

MeSH Terms

Conditions

Endometriosis

Interventions

elagolix

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

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: November 21, 2008
• First Posted: November 25, 2008
• Study Start: November 26, 2008
• Primary Completion: February 24, 2010
• Study Completion: February 24, 2010
• Last Updated: September 10, 2018
• Results First Posted: September 10, 2018

Record last verified: 2018-04