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Completed

NCT Number: NCT03213457

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

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 participants including the safety and efficacy of elagolix in combination with concomitant hormonal add-back therapy.

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Key information

Conditions

Endometriosis Dysmenorrhea Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms Urogenital Diseases

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Strand Clinic /ID# 152582, St. John's, Newfoundland and Labrador, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • At least 2 days of "moderate" or "severe" dysmenorrhea (DYS) AND either
  • At least 2 days of "moderate" or "severe" non-menstrual pelvic pain (NMPP) and an average NMPP score of at least 1.0, OR
  • 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:
  • 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
  • a clinically significant medical condition that is anticipated to require intervention during the course of study participation (e.g., anticipated major elective surgery) OR
  • 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.

Treatment and study plan

Estradiol/norethindrone acetate

Drug

Tablets

Other names: Activella, E2/NETA

Placebo for Elagolix

Drug

Tablet

Elagolix

Drug

Tablet

Other names: ABT-620, Elagolix Sodium, ORILISSA

Placebo for E2/NETA

Drug

Tablets

Primary outcomes

  1. Co-Primary Endpoint: Percentage of Participants With a Response for Dysmenorrhea (DYS) at Months 6 and 12 Based on Daily Assessment

    Time frame: Month 6, Month 12

    Participants recorded rescue analgesic use for endometriosis-associated pain daily and DYS (pain during menstruation ) and its impact on daily activities each day of their period in an electronic diary (e-Diary). DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:

    • 0: No discomfort
    • 1: Mild discomfort but I was easily able to do the things I usually do
    • 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
    • 3: Severe pain that made it difficult to do the things I usually do.

    Pain scores and analgesic use were averaged over 35 days prior to each visit.

    Response was defined as a reduction of -0.92 or more from baseline in DYS as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average rescue analgesic pill count and no additional analgesic).

  2. Co-Primary Endpoint: Percentage of Participants With a Response for Non-menstrual Pelvic Pain (NMPP) at Months 6 and 12 Based on Daily Assessment

    Time frame: Month 6, Month 12

    Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:

    • 0: No discomfort
    • 1: Mild discomfort but I was easily able to do the things I usually do
    • 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
    • 3: Severe pain that made it difficult to do the things I usually do.

    Pain scores and analgesic use were averaged over the 35 days prior to each visit.

    Response was defined as a reduction of -0.55 or greater from baseline for NMPP as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average pill count of rescue analgesics and no additional analgesics).

Secondary outcomes

  1. Change From Baseline in DYS at Month 12 Based on Daily Assessment

    Time frame: Baseline, Month 12

    Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:

    • 0: No discomfort
    • 1: Mild discomfort but I was easily able to do the things I usually do
    • 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
    • 3: Severe pain that made it difficult to do the things I usually do.

    Pain scores were averaged over the 35 days prior to each visit.

  2. Change From Baseline in DYS at Month 6 Based on Daily Assessment

    Time frame: Baseline, Month 6

    Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:

    0: No discomfort

    • Mild discomfort but I was easily able to do the things I usually do
    • Moderate discomfort or pain that made it difficult to do some of the things I usually do
    • Severe pain that made it difficult to do the things I usually do.

    Pain scores were averaged over the 35 days prior to each visit.

  3. Change From Baseline in DYS at Month 3 Based on Daily Assessment

    Time frame: Baseline, Month 3

    Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:

    0: No discomfort

    • Mild discomfort but I was easily able to do the things I usually do
    • Moderate discomfort or pain that made it difficult to do some of the things I usually do
    • Severe pain that made it difficult to do the things I usually do.

    Pain scores were averaged over the 35 days prior to each visit.

  4. Change From Baseline in Non-menstrual Pelvic Pain (NMPP) at Month 12 Based on Daily Assessment

    Time frame: Baseline, Month 12

    Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:

    • 0: No discomfort
    • 1: Mild discomfort but I was easily able to do the things I usually do
    • 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
    • 3: Severe pain that made it difficult to do the things I usually do.

    Pain scores and analgesic use were averaged over the 35 days prior to each visit.

  5. Change From Baseline in NMPP at Month 6 Based on Daily Assessment

    Time frame: Baseline, Month 6

    Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:

    • 0: No discomfort
    • 1: Mild discomfort but I was easily able to do the things I usually do
    • 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
    • 3: Severe pain that made it difficult to do the things I usually do.

    Pain scores and analgesic use were averaged over the 35 days prior to each visit.

  6. Change From Baseline in NMPP at Month 3 Based on Daily Assessment

    Time frame: Baseline, Month 3

    Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:

    • 0: No discomfort
    • 1: Mild discomfort but I was easily able to do the things I usually do
    • 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
    • 3: Severe pain that made it difficult to do the things I usually do.

    Pain scores and analgesic use were averaged over the 35 days prior to each visit.

  7. Change From Baseline to Month 6 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score

    Time frame: Baseline, Month 6

    The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 6a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from baseline) indicates improvement in fatigue.

  8. Change From Baseline in Dyspareunia (DYSP) at Month 12 Based on Daily Assessment

    Time frame: Baseline, Month 12

    Participants assessed DYSP each day in an e-Diary according to the following response options:

    • 0: None; No discomfort during sexual intercourse
    • 1: Mild; Able to tolerate the discomfort during sexual intercourse
    • 2: Moderate; Intercourse was interrupted due to pain
    • 3: Severe; Avoided intercourse because of pain
    • Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse.

    Pain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.

  9. Change From Baseline in DYSP at Month 6 Based on Daily Assessment

    Time frame: Baseline, Month 6

    Participants assessed DYSP each day in an e-Diary according to the following response options:

    • 0: None; No discomfort during sexual intercourse
    • 1: Mild; Able to tolerate the discomfort during sexual intercourse
    • 2: Moderate; Intercourse was interrupted due to pain
    • 3: Severe; Avoided intercourse because of pain
    • Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse.

    Pain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.

  10. Change From Baseline in DYSP at Month 3 Based on Daily Assessment

    Time frame: Baseline, Month 3

    Participants assessed DYSP each day in an e-Diary according to the following response options:

    • 0: None; No discomfort during sexual intercourse
    • 1: Mild; Able to tolerate the discomfort during sexual intercourse
    • 2: Moderate; Intercourse was interrupted due to pain
    • 3: Severe; Avoided intercourse because of pain
    • Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse.

    Pain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.

  11. Change From Baseline to Month 12 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score

    Time frame: Baseline, Month 12

    The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 6a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from baseline) indicates improvement in fatigue.

  12. Change From Baseline in Endometriosis-Associated Pain Score at Month 12 Assessed With Numeric Rating Scale (NRS)

    Time frame: Baseline, Month 12

    The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit.

  13. Change From Baseline in Endometriosis-Associated Pain Score at Month 6 Assessed With NRS

    Time frame: Baseline, Month 6

    The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit.

  14. Change From Baseline in Endometriosis-Associated Pain Score at Month 3 Assessed With NRS

    Time frame: Baseline, Month 3

    The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2023
First posted
Jul 11, 2017
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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