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

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ClinicalTrials.gov Identifier: NCT03343067
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: Elagolix Drug: Estradiol/Norethindrone acetate (E2/NETA) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 890 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 27, 2017
Estimated Primary Completion Date : October 18, 2021
Estimated Study Completion Date : November 17, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Experimental: Arm C
Incomplete efficacy responders to elagolix dose A at Month 3 and randomized to elagolix dose B plus E2/NETA
Drug: Elagolix
Tablets

Drug: Estradiol/Norethindrone acetate (E2/NETA)
Capsules

Experimental: Arm A
Efficacy responders to elagolix dose A at Month 3
Drug: Elagolix
Tablets

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
Drug: Elagolix
Tablets

Experimental: Arm B
Incomplete efficacy responders to elagolix dose A at Month 3 and randomized to elagolix dose A.
Drug: Elagolix
Tablets

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
Drug: Elagolix
Tablets

Drug: Estradiol/Norethindrone acetate (E2/NETA)
Capsules




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. Bone Mineral Density (BMD) evaluation [ Time Frame: Up to Month 24 ]
    This is measured using dual energy x-ray absorptiometry (DXA).


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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).

  4. 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).

  5. 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).

  6. Change from baseline in dyspareunia [ Time Frame: From Month 0 (baseline) to Month 6 ]
    This will be assessed using e-Diary.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03343067


Contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

  Show 44 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03343067     History of Changes
Other Study ID Numbers: M16-383
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by AbbVie:
Endometriosis associated pain
Elagolix
Non-menstrual pelvic pain (NMPP)
Dysmenorrhea (DYS)

Additional relevant MeSH terms:
Genital Diseases, Female
Endometriosis
Estradiol
Norethindrone
Norethindrone acetate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents