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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01931670




Registration number
NCT01931670
Ethics application status
Date submitted
27/08/2013
Date registered
29/08/2013

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
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
Secondary ID [1] 0 0
2011-004295-11
Secondary ID [2] 0 0
M12-671
Universal Trial Number (UTN)
Trial acronym
ELARIS EM-II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS)
Timepoint [1] 0 0
At Month 3 of the Treatment Period
Primary outcome [2] 0 0
Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP)
Timepoint [2] 0 0
At Month 3 of Treatment Period
Secondary outcome [1] 0 0
Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores
Timepoint [1] 0 0
Baseline, Month 3 of the Treatment Period
Secondary outcome [2] 0 0
Change From Baseline to Month 6 in DYS
Timepoint [2] 0 0
Baseline, Month 6 of Treatment Period
Secondary outcome [3] 0 0
Change From Baseline to Month 6 in NMPP
Timepoint [3] 0 0
Baseline, Month 6 of Treatment Period
Secondary outcome [4] 0 0
Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics
Timepoint [4] 0 0
Baseline, Month 3 of Treatment Period
Secondary outcome [5] 0 0
Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics
Timepoint [5] 0 0
Baseline, Month 6 of Treatment Period
Secondary outcome [6] 0 0
Change From Baseline to Month 3 in Dyspareunia (DYSP)
Timepoint [6] 0 0
Baseline, Month 3 of Treatment Period
Secondary outcome [7] 0 0
Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids)
Timepoint [7] 0 0
Baseline, Month 3 of Treatment Period
Secondary outcome [8] 0 0
Percentage of Responders for Each Month, Except Month 3, in DYS
Timepoint [8] 0 0
Months 1, 2, 4, 5, 6 of the Treatment Period
Secondary outcome [9] 0 0
Percentage of Responders for Each Month, Except Month 3, in NMPP
Timepoint [9] 0 0
Months 1, 2, 4, 5, 6 of the Treatment Period
Secondary outcome [10] 0 0
Percentage of Responders at Each Month for DYSP
Timepoint [10] 0 0
Months 1, 2, 3, 4, 5, 6 of Treatment Period
Secondary outcome [11] 0 0
Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS
Timepoint [11] 0 0
Baseline (Prior to administering study drug), Months 1, 2, 3, 4, 5 of Treatment Period
Secondary outcome [12] 0 0
Percent Change From Baseline to Each Month in Mean Pain Score for DYS
Timepoint [12] 0 0
Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
Secondary outcome [13] 0 0
Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP
Timepoint [13] 0 0
Baseline, Months 1, 2, 3, 4, 5 of Treatment Period
Secondary outcome [14] 0 0
Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP
Timepoint [14] 0 0
Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
Secondary outcome [15] 0 0
Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP
Timepoint [15] 0 0
Baseline, Months 1, 2, 4, 5, 6 of Treatment Period
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
Timepoint [16] 0 0
Baseline, Months 1, 2, 4, 5
Secondary outcome [17] 0 0
Patient Global Impression of Change (PGIC) Questionnaire
Timepoint [17] 0 0
Months 1, 2, 3, 4, 5, 6 of Treatment Period
Secondary outcome [18] 0 0
Change From Baseline to Each Month, Except Month 3, in NRS Scores
Timepoint [18] 0 0
Baseline, Months 1, 2, 4, 5, 6 of Treatment Period
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
Timepoint [19] 0 0
Baseline, Months 1, 3, 6 of Treatment Period
Secondary outcome [20] 0 0
Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores
Timepoint [20] 0 0
Baseline, Months 1, 3, 6 of Treatment Period
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
Timepoint [21] 0 0
Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
Secondary outcome [22] 0 0
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism
Timepoint [22] 0 0
Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
Secondary outcome [23] 0 0
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism
Timepoint [23] 0 0
Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
Secondary outcome [24] 0 0
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism
Timepoint [24] 0 0
Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
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
Timepoint [25] 0 0
Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
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
Timepoint [26] 0 0
Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
Secondary outcome [27] 0 0
Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period
Timepoint [27] 0 0
Months 1, 2, 3, 4, 5, 6 of Treatment Period
Secondary outcome [28] 0 0
Number of Days of Hospitalization
Timepoint [28] 0 0
Up to Month 6 of Treatment Period
Secondary outcome [29] 0 0
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type
Timepoint [29] 0 0
Up to Month 6 of Treatment Period

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.
Minimum age
18 Years
Maximum age
49 Years
Sex
Females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/12/2016
Sample size
Target
Accrual to date
Final
815
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Taylor HS, Giudice LC, Lessey BA, Abrao MS, Kotars... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT01931670