Clinical trial NCT01931670: A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endometriosis
Keywords: Non-Menstrual Pelvic Pain (NMPP)
Dysmenorrhea (DYS)
Elagolix
Endometriosis Associated Pain
Gonadotropin-Releasing Hormone Antagonist
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2013-08-29
Enrollment: 815
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female subjects.

Detailed description: The study consists of 4 periods: 1) Washout Period (if applicable); 2) a Screening Period of up to 100 days prior to first dose; 3) a 6 month Treatment Period; and 4) a Post treatment Follow-up Period of up to 12 months (if applicable). An electronic diary will be dispensed and training provided to record endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis-associated pain on a daily basis. Pregnancy testing will be performed monthly throughout the study. Subjects will be required to use nonhormonal dual contraception during the study, and will be counseled on appropriate and effective forms of birth control to promote pregnancy prevention.

Eligibility criteria: Inclusion Criteria:

1. Premenopausal female, between 18 and 49 years of age, inclusive, at the time of signing consent.
2. Clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into the Washout Period.
3. Agrees to use required birth control methods during the entire length of participation in the study.
4. Subject has a Composite Pelvic Signs and Symptoms Score total score of 6 or greater at Screening with a score of at least 2 for dysmenorrhea AND at least 2 for non-menstrual pelvic pain.
5. Subjects must have at least two regular menstrual cycles with an interval of 24-38 days within the Screening Period, prior to Day 1.

Exclusion Criteria:

1. Subject is pregnant or breast feeding or is planning a pregnancy within the next 24 months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the time of entry into the Screening Period.
2. Subject has a history of previous non-response to gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists, Depot medroxyprogesterone acetate, or aromatase inhibitors as assessed by subject report of no improvement in dysmenorrhea or non-menstrual pelvic pain.
3. Subject has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain.
4. Clinically significant gynecologic condition identified on Screening transvaginal ultrasound or endometrial biopsy.
5. Subject has a history of osteoporosis or other metabolic bone disease.
6. Subject has a current history of undiagnosed abnormal uterine bleeding.

Primary outcomes:
measure: Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS)
timeFrame: At Month 3 of the Treatment Period
measure: Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP)
timeFrame: At Month 3 of Treatment Period
Secondary outcomes:
measure: Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores
timeFrame: Baseline, Month 3 of the Treatment Period
measure: Change From Baseline to Month 6 in DYS
timeFrame: Baseline, Month 6 of Treatment Period
measure: Change From Baseline to Month 6 in NMPP
timeFrame: Baseline, Month 6 of Treatment Period
measure: Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics
timeFrame: Baseline, Month 3 of Treatment Period
measure: Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics
timeFrame: Baseline, Month 6 of Treatment Period
measure: Change From Baseline to Month 3 in Dyspareunia (DYSP)
timeFrame: Baseline, Month 3 of Treatment Period
measure: Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids)
timeFrame: Baseline, Month 3 of Treatment Period
measure: Percentage of Responders for Each Month, Except Month 3, in DYS
timeFrame: Months 1, 2, 4, 5, 6 of the Treatment Period
measure: Percentage of Responders for Each Month, Except Month 3, in NMPP
timeFrame: Months 1, 2, 4, 5, 6 of the Treatment Period
measure: Percentage of Responders at Each Month for DYSP
timeFrame: Months 1, 2, 3, 4, 5, 6 of Treatment Period
measure: Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS
timeFrame: Baseline (Prior to administering study drug), Months 1, 2, 3, 4, 5 of Treatment Period
measure: Percent Change From Baseline to Each Month in Mean Pain Score for DYS
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
measure: Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP
timeFrame: Baseline, Months 1, 2, 3, 4, 5 of Treatment Period
measure: Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
measure: Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP
timeFrame: Baseline, Months 1, 2, 4, 5, 6 of Treatment Period
measure: Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics
timeFrame: Baseline, Months 1, 2, 4, 5
measure: Patient Global Impression of Change (PGIC) Questionnaire
timeFrame: Months 1, 2, 3, 4, 5, 6 of Treatment Period
measure: Change From Baseline to Each Month, Except Month 3, in NRS Scores
timeFrame: Baseline, Months 1, 2, 4, 5, 6 of Treatment Period
measure: Change From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores
timeFrame: Baseline, Months 1, 3, 6 of Treatment Period
measure: Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores
timeFrame: Baseline, Months 1, 3, 6 of Treatment Period
measure: Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
measure: Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
measure: Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
measure: Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
measure: Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
measure: Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
measure: Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period
timeFrame: Months 1, 2, 3, 4, 5, 6 of Treatment Period
measure: Number of Days of Hospitalization
timeFrame: Up to Month 6 of Treatment Period
measure: Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type
timeFrame: Up to Month 6 of Treatment Period
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
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