Extension Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Subjects with Moderate to Severe Endometriosis-Associated Pain

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001047-31-CZ

Enrollment

523

Registered

2014-02-24

Start date

2014-05-14

Completion date

Unknown

Last updated

2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to Severe Endometriosis Associated Pain MedDRA version: 19.0 Level: LLT Classification code 10014788 Term: Endometriosis related pain System Organ Class: 100000004872

Interventions

Product Name: Elagolix-200mg Product Code: ABT-620 Pharmaceutical Form: Tablet INN or Proposed INN: Elagolix CAS Number: 832720-36-2 Current Sponsor code: ABT-620 Other descriptive name: Elagolix Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subject has voluntarily signed and dated the informed consent form (ICF), approved by an Institutional Review Board/Ethics Committee (IRB/EC) prior to initiation of any study-specific procedures. 2. Subject has completed the 6-Month Treatment Period in pivotal study M12-671. 3. Subject must agree to use two forms of non-hormonal contraception (dual contraception) consistently during the Treatment and the Post-Treatment Follow-Up Periods (through Month 6). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 523 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Pivotal study M12-671 Month 6 TVU or other diagnostic procedure shows clinically significant gynecological condition 2. Subject has BMD loss = 8% in the spine, femoral neck or total hip as specified per the algorithm for Management of Bone Loss at Month 6 of the Treatment Period in pivotal Study M12-671. 3. Subject met criteria for removal from therapy in pivotal Study M12-671. 4. Subject plans to become pregnant in the next 18 months. 5. Subject will be unable or unwilling to comply with study-related assessments and procedures 6. Subject has a newly diagnosed or clinically significant medical condition that requires intervention OR an unstable medical condition that makes the subject an unsuitable candidate for the study in the opinion of the investigator.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this 6-month extension study is to evaluate the continued safety, efficacy and tolerability of the 150 mg QD and 200 mg BID doses of elagolix (ABT-620) for up to 12 months in the management of moderate to severe endometriosis-associated pain. Safety and tolerability will include assessments of BMD via dual-energy x-ray absorptiometry (DXA) including effects of long term treatment and post-treatment recovery during an up to 12-month Post-Treatment Period and evaluation of endometrial health via transvaginal ultrasound (TVU). ;Secondary Objective: The secondary objective is to assess the population PK and PD of elagolix.;Primary end point(s): Proportion of responders at each month based upon the mutually-exclusive scales for daily assessment of DYS and NMPP measured by the Daily Assessment of Endometriosis Pain (modified Biberoglu and Behrman [B&B] scales using the e-Diary); use of analgesic medication for endometriosis-associated pain will be included in the responder definition.;Timepoint(s) of evaluation of this end point: Day 1, Month 1-Month 6 in the treatment periood and Month 1-Month6 in the Post-Treatment Follow-Up Period.	—

Measure

Time frame

Main Objective: The primary objective of this 6-month extension study is to evaluate the continued safety, efficacy and tolerability of the 150 mg QD and 200 mg BID doses of elagolix (ABT-620) for up to 12 months in the management of moderate to severe endometriosis-associated pain. Safety and tolerability will include assessments of BMD via dual-energy x-ray absorptiometry (DXA) including effects of long term treatment and post-treatment recovery during an up to 12-month Post-Treatment Period and evaluation of endometrial health via transvaginal ultrasound (TVU). ;Secondary Objective: The secondary objective is to assess the population PK and PD of elagolix.;Primary end point(s): Proportion of responders at each month based upon the mutually-exclusive scales for daily assessment of DYS and NMPP measured by the Daily Assessment of Endometriosis Pain (modified Biberoglu and Behrman [B&B] scales using the e-Diary); use of analgesic medication for endometriosis-associated pain will be included in the responder definition.;Timepoint(s) of evaluation of this end point: Day 1, Month 1-Month 6 in the treatment periood and Month 1-Month6 in the Post-Treatment Follow-Up Period.

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Secondary

Measure	Time frame
Secondary end point(s): • Proportion of responders at each month for dyspareunia as assessed by the e-Diary. • Change from baseline to each month in DYS, as assessed by the e-Diary. • Change from baseline to each month in NMPP, as assessed by the e-Diary. • Change from baseline to each month in dyspareunia, as assessed by the e-Diary. • Change from baseline to each month in analgesic use to treat endometriosis-related pain, as assessed by the e-Diary. • Results of Endometriosis Health Profile-30(EHP-30) domain of pain at each assessed visit. • Results of EHP-30 domain of sexual relationship at each assessed visit • Summary of Health Related Productivity Questionnaire scores by visit (HRPQ). • Endometriosis related number of non-study health visits, number of days in hospital and type of procedures performed based on Health Resource Utilization Questionnaire (HRUQ). • Change from baseline to each month in Numeric Rating Scale (NRS) scores, as assessed by the e-Diary. • Response at each month to the Patient Global Impression of Change (PGIC) questionnaire. ;Timepoint(s) of evaluation of this end point: Treatment Period until Month 6/PD. During the Post-Treatment Follow-Up Period, daily assessments will be recorded in the e Diary through Follow-Up Month 6.	—

Measure

Time frame

Secondary end point(s): • Proportion of responders at each month for dyspareunia as assessed by the e-Diary. • Change from baseline to each month in DYS, as assessed by the e-Diary. • Change from baseline to each month in NMPP, as assessed by the e-Diary. • Change from baseline to each month in dyspareunia, as assessed by the e-Diary. • Change from baseline to each month in analgesic use to treat endometriosis-related pain, as assessed by the e-Diary. • Results of Endometriosis Health Profile-30(EHP-30) domain of pain at each assessed visit. • Results of EHP-30 domain of sexual relationship at each assessed visit • Summary of Health Related Productivity Questionnaire scores by visit (HRPQ). • Endometriosis related number of non-study health visits, number of days in hospital and type of procedures performed based on Health Resource Utilization Questionnaire (HRUQ). • Change from baseline to each month in Numeric Rating Scale (NRS) scores, as assessed by the e-Diary. • Response at each month to the Patient Global Impression of Change (PGIC) questionnaire. ;Timepoint(s) of evaluation of this end point: Treatment Period until Month 6/PD. During the Post-Treatment Follow-Up Period, daily assessments will be recorded in the e Diary through Follow-Up Month 6.

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Countries

Argentina, Australia, Austria, Brazil, Czech Republic, Hungary, Italy, New Zealand, Poland, South Africa, Spain, United Kingdom, United States

Contacts

Public ContactEU Clinical Trials Helpdesk

AbbVie Ltd

eu-clinical-trials@abbvie.com+441628561090

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026