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A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated 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: NCT03213457
Recruitment Status : Active, not recruiting
First Posted : July 11, 2017
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE July 7, 2017
First Posted Date  ICMJE July 11, 2017
Last Update Posted Date May 3, 2019
Actual Study Start Date  ICMJE July 7, 2017
Estimated Primary Completion Date January 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03213457 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2018)
  • Change from baseline in Dysmenorrhea (DYS) [ Time Frame: From Month 0 (baseline) at Month 3, Month 6 and Month 12 ]
    It is measured by the Endometriosis Daily Pain Impact scale in the eDiary.
  • Change from baseline in dyspareunia [ Time Frame: From Month 0 (baseline) at Month 3, Month 6 and Month 12 ]
    This will be assessed using e-Diary.
  • Change from baseline in Numeric Rating Scale (NRS) [ Time Frame: From Month 0 (baseline) at Month 3, Month 6 and Month 12 ]
    This is assessed using overall endometriosis associated pain questionnaire, 11-point Numeric Rating Scale (NRS).
  • Change from baseline in Non-menstrual pelvic pain (NMPP) [ Time Frame: From Month 0 (baseline) at Month 3, Month 6 and Month 12 ]
    It is measured by the Endometriosis Daily Pain Impact scale in the eDiary.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2017)
  • Change from baseline in Numeric Rating Scale (NRS) [ Time Frame: From Month 0 (baseline) to Month 12 ]
    This is assessed using overall endometriosis associated pain questionnaire, 11-point Numeric Rating Scale (NRS).
  • Change from baseline in Dysmenorrhea (DYS) [ Time Frame: From Month 0 (baseline) to Month 12 ]
    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 12 ]
    It is measured by the Endometriosis Daily Pain Impact scale in the eDiary.
  • Change from baseline in analgesic use across both classes of rescue analgesics based on total pill counts [ Time Frame: From Month 0 (baseline) to Month 12 ]
    This will be assessed using e-Diary.
  • Change from baseline in dyspareunia [ Time Frame: From Month 0 (baseline) to Month 12 ]
    This will be assessed using e-Diary.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain
Official Title  ICMJE A Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Combination With Estradiol/Norethindrone Acetate in Subjects With Moderate to Severe Endometriosis-Associated Pain
Brief Summary The objective of this study is to evaluate safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female subjects including the safety and efficacy of elagolix in combination with concomitant hormonal add-back therapy.
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: Estradiol/Norethindrone Acetate
    Capsules
  • Other: Placebo for Elagolix
    Tablet
  • Drug: Elagolix
    Tablet
    Other Names:
    • ABT-620
    • Elagolix Sodium
  • Other: Placebo for E2/NETA
    Capsules
Study Arms  ICMJE
  • Experimental: Elagolix + Estradiol/Norethindrone Acetate (E2/NETA)
    Elagolix administered twice daily and Estradiol/Norethindrone Acetate (E2/NETA) administered once daily
    Interventions:
    • Drug: Estradiol/Norethindrone Acetate
    • Drug: Elagolix
  • Experimental: Elagolix
    It is administered twice daily.
    Interventions:
    • Drug: Elagolix
    • Other: Placebo for E2/NETA
  • Placebo Comparator: Placebo
    A matching placebo for Elagolix and E2/NETA are administered.
    Interventions:
    • Other: Placebo for Elagolix
    • Other: Placebo for 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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 1, 2019)
680
Original Estimated Enrollment  ICMJE
 (submitted: July 7, 2017)
700
Estimated Study Completion Date  ICMJE March 30, 2021
Estimated Primary Completion Date January 2, 2020   (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 within 10 years prior to entry into Washout or Screening.
  • Participant must agree to use only protocol specified rescue analgesics during the Screening and Treatment Periods for 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" Dysmenorrhea (DYS) AND either
    2. At least 2 days of "moderate" or "severe" Non-menstrual pelvic pain (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-related 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 any major depression or post-traumatic stress disorder (PTSD) within 2 years of the screening visit 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) within the last 1 year at Screening or prior to randomization on Day 1.
  • Participant has any history of osteoporosis or other metabolic bone disease or any condition that would interfere with obtaining adequate Dual Energy X-Ray Absorptiometry (DXA) measurements
  • Screening DXA results of the lumbar spine (L1-L4), femoral neck or total hip Bone Mineral Density (BMD) corresponding to less than 2.0 or more standard deviations below normal.
  • 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 randomization on Day 1 OR
    2. a clinically significant medical condition that is anticipated to require intervention during the course of study participation (e.g., anticipated major elective surgery) OR
    3. an unstable medical condition that makes the subject an unsuitable candidate for the study in the opinion of the Investigator, (including, but not limited to, uncontrolled diabetes mellitus, uncontrolled hypertension, epilepsy requiring anti-epileptic medication, unstable angina, confirmed inflammatory bowel disease, hyperprolactinemia, clinically significant infection or injury).
  • 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,   Puerto Rico,   United States
Removed Location Countries American Samoa
 
Administrative Information
NCT Number  ICMJE NCT03213457
Other Study ID Numbers  ICMJE M14-702
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 May 2019

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