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

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ClinicalTrials.gov Identifier: NCT01760954
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
A randomized study evaluating the continued safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult pre-menopausal female subjects who completed the 6 month treatment period in the pivotal study M12-665.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: Elagolix Other: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 506 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Extension Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
Study Start Date : December 2012
Primary Completion Date : May 2015
Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Elagolix Dose 1
Elagolix dose 1 for 6 month treatment period.
Drug: Elagolix Other: Placebo
(To maintain blind)
Experimental: Elagolix Dose 2
Elagolix dose 2 for 6 month treatment period.
Drug: Elagolix


Outcome Measures

Primary Outcome Measures :
  1. Proportion of responders at Month 6 based on daily assessment of dysmenorrhea (DYS) [ Time Frame: At Month 6 of the Treatment Period ]
    via e-Diary

  2. Proportion of responders at Month 6 based on daily assessment of non-menstrual pelvic pain (NMPP) [ Time Frame: At Month 6 of the Treatment Period ]
    via e-Diary


Secondary Outcome Measures :
  1. Proportion of responders at each month for dyspareunia [ Time Frame: Up to Month 6 of Treatment Period ]
    via eDiary

  2. Change from baseline to each month in dysmenorrhea (DYS) [ Time Frame: Up to Month 6 of Treatment Period ]
    via eDiary

  3. Change from baseline to each month in non-menstrual pelvic pain (NMPP) [ Time Frame: From Baseline (prior to study drug administration) to Month 6 of Treatment Period ]
    via eDiary

  4. Change from baseline to each month in dyspareunia [ Time Frame: From Baseline (prior to study drug administration) to Month 6 of Treatment Period ]
    via eDiary

  5. Change from baseline to each month in analgesic use to treat endometriosis-related pain [ Time Frame: From Baseline (prior to study drug administration) to Month 6 of Treatment Period ]
    via eDiary

  6. Results of Endometriosis Health Profile-30 (EHP-30) domain of pain at each assessed visit [ Time Frame: Up to Month 6 of Treatment Period ]
    EHP-30 questionnaire

  7. Results of EHP-30 domain of sexual relationship at each assessed visit [ Time Frame: Up to Month 6 of Treatment Period ]
    EHP-30 questionnaire

  8. Summary of Health Related Productivity Questionnaire (HRPQ) scores by visit [ Time Frame: Up to Month 6 of Treatment Period ]
    HRPQ

  9. Number of endometriosis-related non-study health visits [ Time Frame: Up to Month 6 of Treatment Period ]
    Health Resource Utilization Questionnaire (HRUQ)

  10. Number of days in hospital [ Time Frame: Up to Month 6 of Treatment Period ]
    HRUQ

  11. Type of procedures performed [ Time Frame: Up to Month 6 of Treatment Period ]
    HRUQ

  12. Change from baseline to each month in Numeric Rating Scale (NRS) scores [ Time Frame: Up to Month 6 of Treatment Period ]
    via eDiary

  13. Response at each month to the Patient Global Impression of Change (PGIC) questionnaire [ Time Frame: Up to Month 6 of Treatment Period ]
    PGIC questionnaire


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completed the 6 month Treatment Period in pivotal study M12-665 (NCT01620528)
  • Agrees to use required birth control methods during the study through Month 6 of the Post-treatment Follow-up period

Exclusion Criteria:

  • Clinically significant condition
  • Bone mineral density (BMD) loss greater than or equal to 8 percent in the spine, femoral neck or total hip
  • Plans to become pregnant in the next 18 months
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760954


  Show 149 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Rachel W Duan, MD AbbVie
More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01760954     History of Changes
Other Study ID Numbers: M12-667
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018

Keywords provided by AbbVie:
Gonadotropin-Releasing Hormone Antagonist
Non-Menstrual Pelvic Pain (NMPP)
Dysmenorrhea (DYS)
Endometriosis associated pain
Elagolix

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female