Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01931670
Registration number
NCT01931670
Ethics application status
Date submitted
27/08/2013
Date registered
29/08/2013
Date last updated
7/09/2018
Titles & IDs
Public title
A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
2011-004295-11
Query!
Secondary ID [2]
0
0
M12-671
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
ELARIS EM-II
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Endometriosis
0
0
Query!
Condition category
Condition code
Reproductive Health and Childbirth
0
0
0
0
Query!
Other reproductive health and childbirth disorders
Query!
Reproductive Health and Childbirth
0
0
0
0
Query!
Menstruation and menopause
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Other interventions - placebo
Treatment: Drugs - Elagolix
Placebo Comparator: Placebo - Placebo twice daily (BID) for the 6-month Treatment Period
Experimental: Elagolix 150 mg QD - Elagolix 150 mg once daily (QD) for the 6-month Treatment Period
Experimental: Elagolix 200 mg BID - Elagolix 200 mg BID for the 6-month Treatment Period
Other interventions: placebo
Treatment: Drugs: Elagolix
Query!
Intervention code [1]
0
0
Other interventions
Query!
Intervention code [2]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS)
Query!
Assessment method [1]
0
0
The DYS pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain.
Query!
Timepoint [1]
0
0
At Month 3 of the Treatment Period
Query!
Primary outcome [2]
0
0
Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP)
Query!
Assessment method [2]
0
0
The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain.
Query!
Timepoint [2]
0
0
At Month 3 of Treatment Period
Query!
Secondary outcome [1]
0
0
Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores
Query!
Assessment method [1]
0
0
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Query!
Timepoint [1]
0
0
Baseline, Month 3 of the Treatment Period
Query!
Secondary outcome [2]
0
0
Change From Baseline to Month 6 in DYS
Query!
Assessment method [2]
0
0
The DYS pain scale ranges from 0 (none) to 3 (severe).
Query!
Timepoint [2]
0
0
Baseline, Month 6 of Treatment Period
Query!
Secondary outcome [3]
0
0
Change From Baseline to Month 6 in NMPP
Query!
Assessment method [3]
0
0
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Query!
Timepoint [3]
0
0
Baseline, Month 6 of Treatment Period
Query!
Secondary outcome [4]
0
0
Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics
Query!
Assessment method [4]
0
0
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts.
Query!
Timepoint [4]
0
0
Baseline, Month 3 of Treatment Period
Query!
Secondary outcome [5]
0
0
Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics
Query!
Assessment method [5]
0
0
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts.
Query!
Timepoint [5]
0
0
Baseline, Month 6 of Treatment Period
Query!
Secondary outcome [6]
0
0
Change From Baseline to Month 3 in Dyspareunia (DYSP)
Query!
Assessment method [6]
0
0
The DYSP pain scale ranges from 0 (absent) to 3 (severe).
Query!
Timepoint [6]
0
0
Baseline, Month 3 of Treatment Period
Query!
Secondary outcome [7]
0
0
Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids)
Query!
Assessment method [7]
0
0
Permitted country-specific rescue narcotic analgesics included 5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen. Assessment was based on average pill counts.
Query!
Timepoint [7]
0
0
Baseline, Month 3 of Treatment Period
Query!
Secondary outcome [8]
0
0
Percentage of Responders for Each Month, Except Month 3, in DYS
Query!
Assessment method [8]
0
0
The DYS pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain.
Query!
Timepoint [8]
0
0
Months 1, 2, 4, 5, 6 of the Treatment Period
Query!
Secondary outcome [9]
0
0
Percentage of Responders for Each Month, Except Month 3, in NMPP
Query!
Assessment method [9]
0
0
The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain.
Query!
Timepoint [9]
0
0
Months 1, 2, 4, 5, 6 of the Treatment Period
Query!
Secondary outcome [10]
0
0
Percentage of Responders at Each Month for DYSP
Query!
Assessment method [10]
0
0
The DYSP pain scale ranged from 0 (absent) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.29 or greater from Baseline in DYSP as well as no increased rescue analgesic use for endometriosis-associated pain.
Query!
Timepoint [10]
0
0
Months 1, 2, 3, 4, 5, 6 of Treatment Period
Query!
Secondary outcome [11]
0
0
Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS
Query!
Assessment method [11]
0
0
The DYS pain scale ranges from 0 (none) to 3 (severe).
Query!
Timepoint [11]
0
0
Baseline (Prior to administering study drug), Months 1, 2, 3, 4, 5 of Treatment Period
Query!
Secondary outcome [12]
0
0
Percent Change From Baseline to Each Month in Mean Pain Score for DYS
Query!
Assessment method [12]
0
0
The DYS pain scale ranges from 0 (none) to 3 (severe).
Query!
Timepoint [12]
0
0
Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
Query!
Secondary outcome [13]
0
0
Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP
Query!
Assessment method [13]
0
0
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Query!
Timepoint [13]
0
0
Baseline, Months 1, 2, 3, 4, 5 of Treatment Period
Query!
Secondary outcome [14]
0
0
Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP
Query!
Assessment method [14]
0
0
The NMPP pain scale ranges from 0 (none) to 3 (severe).
Query!
Timepoint [14]
0
0
Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
Query!
Secondary outcome [15]
0
0
Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP
Query!
Assessment method [15]
0
0
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Query!
Timepoint [15]
0
0
Baseline, Months 1, 2, 4, 5, 6 of Treatment Period
Query!
Secondary outcome [16]
0
0
Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics
Query!
Assessment method [16]
0
0
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts.
Query!
Timepoint [16]
0
0
Baseline, Months 1, 2, 4, 5
Query!
Secondary outcome [17]
0
0
Patient Global Impression of Change (PGIC) Questionnaire
Query!
Assessment method [17]
0
0
The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
Query!
Timepoint [17]
0
0
Months 1, 2, 3, 4, 5, 6 of Treatment Period
Query!
Secondary outcome [18]
0
0
Change From Baseline to Each Month, Except Month 3, in NRS Scores
Query!
Assessment method [18]
0
0
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Query!
Timepoint [18]
0
0
Baseline, Months 1, 2, 4, 5, 6 of Treatment Period
Query!
Secondary outcome [19]
0
0
Change From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores
Query!
Assessment method [19]
0
0
The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Query!
Timepoint [19]
0
0
Baseline, Months 1, 3, 6 of Treatment Period
Query!
Secondary outcome [20]
0
0
Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores
Query!
Assessment method [20]
0
0
The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Query!
Timepoint [20]
0
0
Baseline, Months 1, 3, 6 of Treatment Period
Query!
Secondary outcome [21]
0
0
Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism
Query!
Assessment method [21]
0
0
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
Query!
Timepoint [21]
0
0
Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
Query!
Secondary outcome [22]
0
0
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism
Query!
Assessment method [22]
0
0
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
Query!
Timepoint [22]
0
0
Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
Query!
Secondary outcome [23]
0
0
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism
Query!
Assessment method [23]
0
0
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.
Query!
Timepoint [23]
0
0
Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
Query!
Secondary outcome [24]
0
0
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism
Query!
Assessment method [24]
0
0
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.
Query!
Timepoint [24]
0
0
Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
Query!
Secondary outcome [25]
0
0
Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace
Query!
Assessment method [25]
0
0
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Query!
Timepoint [25]
0
0
Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
Query!
Secondary outcome [26]
0
0
Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household
Query!
Assessment method [26]
0
0
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Query!
Timepoint [26]
0
0
Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
Query!
Secondary outcome [27]
0
0
Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period
Query!
Assessment method [27]
0
0
This is assessed using Health Resource Utilization Questionnaire (HRUQ).
Query!
Timepoint [27]
0
0
Months 1, 2, 3, 4, 5, 6 of Treatment Period
Query!
Secondary outcome [28]
0
0
Number of Days of Hospitalization
Query!
Assessment method [28]
0
0
This is assessed using HRUQ.
Query!
Timepoint [28]
0
0
Up to Month 6 of Treatment Period
Query!
Secondary outcome [29]
0
0
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type
Query!
Assessment method [29]
0
0
This is assessed using HRUQ.
Query!
Timepoint [29]
0
0
Up to Month 6 of Treatment Period
Query!
Eligibility
Key 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
49
Years
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
9/09/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
19/12/2016
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
815
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
AbbVie
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01931670
Query!
Trial related presentations / publications
Query!
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
Query!
Contacts
Principal investigator
Name
0
0
AbbVie Inc.
Query!
Address
0
0
AbbVie
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01931670
Download to PDF