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

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ClinicalTrials.gov Identifier: NCT03213457
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: Estradiol/Norethindrone Acetate Other: Placebo for Elagolix Drug: Elagolix Other: Placebo for E2/NETA Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 21, 2017
Estimated Primary Completion Date : January 2, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Experimental: Elagolix + Estradiol/Norethindrone Acetate (E2/NETA)
Elagolix administered twice daily and Estradiol/Norethindrone Acetate (E2/NETA) administered once daily
Drug: Estradiol/Norethindrone Acetate
Capsules

Drug: Elagolix
Tablet
Other Names:
  • ABT-620
  • Elagolix Sodium

Experimental: Elagolix
It is administered twice daily.
Drug: Elagolix
Tablet
Other Names:
  • ABT-620
  • Elagolix Sodium

Other: Placebo for E2/NETA
Capsules

Placebo Comparator: Placebo
A matching placebo for Elagolix and E2/NETA are administered.
Other: Placebo for Elagolix
Tablet

Other: Placebo for E2/NETA
Capsules




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.



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 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.

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): NCT03213457


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

  Show 201 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03213457     History of Changes
Other Study ID Numbers: M14-702
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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

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:
Elagolix
Endometriosis associated pain
Dysmenorrhea (DYS)
Non-menstrual pelvic pain (NMPP)

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Estradiol
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Norethindrone
Norethindrone acetate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral