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

Phase 1

• Conditions: Moderate to Severe Endometriosis Associated Pain; MedDRA version: 16.1Level: LLTClassification code 10014788Term: Endometriosis related painSystem Organ Class: 100000004872; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2013-001047-31-IT
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-25
• Study Completion: 2017-05-23
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 495

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 518
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified