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A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03343067
Recruitment Status : Terminated (Strategic considerations)
First Posted : November 17, 2017
Last Update Posted : October 8, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE November 13, 2017
First Posted Date  ICMJE November 17, 2017
Last Update Posted Date October 8, 2018
Actual Study Start Date  ICMJE December 27, 2017
Actual Primary Completion Date September 4, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2018)
  • Proportion of responders based on Non-menstrual pelvic pain (NMPP) [ Time Frame: At Month 6 ]
    It is measured by the Endometriosis Daily Pain Impact scale in the e-Diary. The NMPP pain scale ranges from 0 (none) to 3 (severe).
  • Proportion of responders based on Dysmenorrhea (DYS) [ Time Frame: At Month 6 ]
    It is measured by the Endometriosis Daily Pain Impact scale in the e-Diary. The DYS pain scale ranges from 0 (none) to 3 (severe).
  • Bone Mineral Density (BMD) evaluation [ Time Frame: Up to Month 24 ]
    This is measured using dual energy x-ray absorptiometry (DXA).
Original Primary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
  • Proportion of responders based on Dysmenorrhea (DYS) [ Time Frame: At Month 6 ]
    It is measured by the Endometriosis Daily Pain Impact scale in the e-Diary.
  • Proportion of responders based on Non-menstrual pelvic pain (NMPP) [ Time Frame: At Month 6 ]
    It is measured by the Endometriosis Daily Pain Impact scale in the e-Diary.
  • Bone Mineral Density (BMD) evaluation [ Time Frame: Up to Month 24 ]
    This is measured using dual energy x-ray absorptiometry (DXA).
Change History Complete list of historical versions of study NCT03343067 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2018)
  • Change from baseline in Daily Diary endometriosis-associated pain score [ Time Frame: From Month 0 (baseline) to Month 6 ]
    This is assessed using Numeric Rating Scale (NRS) in the eDiary. The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever).
  • Change from baseline in rescue analgesic use across both classes of rescue analgesics based on average pill counts [ Time Frame: From Month 0 (baseline) to Month 6 ]
    This will be assessed using e-Diary.
  • Percentage of participants with reduction from baseline in endometriosis-associated pain score [ Time Frame: Up to Month 6 ]
    This is assessed using Numeric Rating Scale (NRS) in the eDiary. The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever).
  • Change from baseline in Non-menstrual pelvic pain (NMPP) [ Time Frame: From Month 0 (baseline) to Month 6 ]
    It is measured by the Endometriosis Daily Pain Impact scale in the eDiary. The NMPP pain scale ranges from 0 (none) to 3 (severe).
  • Change from baseline in Dysmenorrhea (DYS) [ Time Frame: From Month 0 (baseline) to Month 6 ]
    It is measured by the Endometriosis Daily Pain Impact scale in the eDiary. The DYS pain scale ranges from 0 (none) to 3 (severe).
  • Change from baseline in dyspareunia [ Time Frame: From Month 0 (baseline) to Month 6 ]
    This will be assessed using e-Diary.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
  • Change from baseline in Dysmenorrhea (DYS) [ Time Frame: From Month 0 (baseline) to Month 6 ]
    It is measured by the Endometriosis Daily Pain Impact scale in the eDiary.
  • Change from baseline in Non-menstrual pelvic pain (NMPP) [ Time Frame: From Month 0 (baseline) to Month 6 ]
    It is measured by the Endometriosis Daily Pain Impact scale in the eDiary.
  • Change from baseline in dyspareunia [ Time Frame: From Month 0 (baseline) to Month 6 ]
    This will be assessed using e-Diary.
  • Change from baseline in Daily Diary endometriosis-associated pain score [ Time Frame: From Month 0 (baseline) to Month 6 ]
    This is assessed using 11-point Numeric Rating Scale (NRS) in the eDiary.
  • Change from baseline in rescue analgesic use across both classes of rescue analgesics based on average pill counts [ Time Frame: From Month 0 (baseline) to Month 6 ]
    This will be assessed using e-Diary.
  • Percentage of participants with reduction from baseline in endometriosis-associated pain score [ Time Frame: Up to Month 6 ]
    This is assessed using Numeric Rating Scale (NRS) in the eDiary.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain
Official Title  ICMJE A Study to Evaluate Safety and Efficacy of Elagolix Alone or Elagolix With Hormonal Add-Back in Subjects With Endometriosis With Associated Moderate to Severe Pain
Brief Summary This is a Phase 3, dose-escalation study designed to evaluate the safety and efficacy of both elagolix alone and elagolix plus Estradiol/Norethindrone acetate (E2/NETA) over 24 months in the management of endometriosis with associated moderate to severe pain in premenopausal women.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Endometriosis
Intervention  ICMJE
  • Drug: Elagolix
    Tablets
  • Drug: Estradiol/Norethindrone acetate (E2/NETA)
    Capsules
Study Arms  ICMJE
  • Experimental: Arm C
    Incomplete efficacy responders to elagolix dose A at Month 3 and randomized to elagolix dose B plus E2/NETA
    Interventions:
    • Drug: Elagolix
    • Drug: Estradiol/Norethindrone acetate (E2/NETA)
  • Experimental: Arm A
    Efficacy responders to elagolix dose A at Month 3
    Intervention: Drug: Elagolix
  • Experimental: Arm E
    Incomplete efficacy responders to elagolix dose A at Month 3, randomized to elagolix dose A treatment group and are efficacy responders at Month 6 continue the same treatment through Month 24
    Intervention: Drug: Elagolix
  • Experimental: Arm B
    Incomplete efficacy responders to elagolix dose A at Month 3 and randomized to elagolix dose A.
    Intervention: Drug: Elagolix
  • Experimental: Arm D
    Incomplete efficacy responders to elagolix dose A at Month 3, randomized to elagolix dose A treatment group and are incomplete efficacy responders at Month 6, and dose increased to elagolix dose B plus E2/NETA through Month 24
    Interventions:
    • Drug: Elagolix
    • Drug: Estradiol/Norethindrone acetate (E2/NETA)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 4, 2018)
11
Original Estimated Enrollment  ICMJE
 (submitted: November 13, 2017)
890
Actual Study Completion Date  ICMJE September 4, 2018
Actual Primary Completion Date September 4, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant is a premenopausal female 18 to 49 years of age (inclusive) at the time of Screening.
  • Participant has a documented surgical diagnosis (e.g., laparoscopy or laparotomy) of endometriosis established by visualization or histology within 10 years prior to entry into Washout or Screening,
  • Participant must agree to use only those rescue analgesics permitted by the protocol during the Screening and Treatment Periods for her endometriosis-associated pain.
  • Participant must have the following documented in the e-Diary during the last 35 days prior to Study Day 1:

    1. At least 2 days of "moderate" or "severe" DYS, AND either,
    2. At least 2 days of "moderate" or "severe" NMPP and an average NMPP score of at least 1.0, OR
    3. At least 4 days of "moderate" or "severe" NMPP and an average NMPP score of at least 0.5.

Exclusion Criteria:

  • Participant has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic therapy, which would interfere with the assessment of endometriosis-associated pain.
  • Participant is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over-the-counter and prescription topical, inhaled or intranasal corticosteroids are allowed.
  • Participant has a history of major depression or post-traumatic stress disorder (PTSD) within 2 years prior to screening or other major psychiatric disorder at any time
  • Participant has a history of suicide attempts or answered "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening or prior to study drug dosing on Day 1.
  • Participant has any condition that would interfere with obtaining adequate DXA measurements
  • Screening DXA results of the lumbar spine (L1 - L4), femoral neck or total hip BMD corresponding to less than 2 or more standard deviations below normal (Z-score < -2.0 for participants < 40 years of age, T-score for participants >= 40 years of age).
  • Participant has either

    1. a newly diagnosed, clinically significant medical condition that requires therapeutic intervention (e.g., new onset hypertension) that has not been stabilized 30 days prior to enrollment on Day 1 OR
    2. a clinically significant medical condition that is anticipated to required intervention during the course of study participation (e.g., anticipated major elective surgery) OR
    3. an unstable medical condition that makes the participant an unsuitable candidate for the study in the opinion of the Investigator
  • Participant has any conditions contraindicated with use of E2/NETA
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03343067
Other Study ID Numbers  ICMJE M16-383
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP