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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02143713




Registration number
NCT02143713
Ethics application status
Date submitted
19/05/2014
Date registered
21/05/2014

Titles & IDs
Public title
Global Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Women With Moderate to Severe Endometriosis-associated Pain
Scientific title
Extension Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
Secondary ID [1] 0 0
2013-001047-31
Secondary ID [2] 0 0
M12-821
Universal Trial Number (UTN)
Trial acronym
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
Treatment: Drugs - Elagolix

Experimental: Elagolix 150 mg QD - Participants received elagolix 150 mg tablets once a day (QD) for 6 months.

Experimental: Elagolix 200 mg BID - Participants received elagolix 200 mg tablets twice a day (BID) for 6 months.


Treatment: Drugs: Elagolix
Elagolix tablets administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With a Response for Dysmenorrhea at Month 6 Based on Daily Assessment
Timepoint [1] 0 0
Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and Month 6
Primary outcome [2] 0 0
Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Month 6 Based on Daily Assessment
Timepoint [2] 0 0
Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and Month 6
Secondary outcome [1] 0 0
Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment
Timepoint [1] 0 0
Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, and 5
Secondary outcome [2] 0 0
Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment
Timepoint [2] 0 0
Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, and 5
Secondary outcome [3] 0 0
Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment
Timepoint [3] 0 0
Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6
Secondary outcome [4] 0 0
Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment
Timepoint [4] 0 0
Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6
Secondary outcome [5] 0 0
Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment
Timepoint [5] 0 0
Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6
Secondary outcome [6] 0 0
Percent Change From Baseline in Dyspareunia Based on Daily Assessment
Timepoint [6] 0 0
Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6
Secondary outcome [7] 0 0
Change From Baseline in Any Rescue Analgesic Use
Timepoint [7] 0 0
Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6
Secondary outcome [8] 0 0
Change From Baseline in NSAID Rescue Analgesic Use
Timepoint [8] 0 0
Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6
Secondary outcome [9] 0 0
Change From Baseline in Opioid Rescue Analgesic Use
Timepoint [9] 0 0
Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6
Secondary outcome [10] 0 0
Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS)
Timepoint [10] 0 0
Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6
Secondary outcome [11] 0 0
Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved
Timepoint [11] 0 0
Months 1, 2, 3, 4, 5, and 6
Secondary outcome [12] 0 0
Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Pain Dimension
Timepoint [12] 0 0
Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 3, and 6
Secondary outcome [13] 0 0
Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Sexual Intercourse Dimension
Timepoint [13] 0 0
Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 3, and 6
Secondary outcome [14] 0 0
Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household
Timepoint [14] 0 0
Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and Month 6
Secondary outcome [15] 0 0
Number of Participants With Non-study Health Visits During the Treatment Period
Timepoint [15] 0 0
6 months
Secondary outcome [16] 0 0
Number of Days in Hospital During the Treatment Period
Timepoint [16] 0 0
6 months

Eligibility
Key inclusion criteria
* Subject has completed the 6-Month Treatment Period in pivotal study M12-671.
* Agrees to use required birth control methods during the study through Month 6 of the Post-treatment Follow-up period
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Clinically significant gynecological condition
* Bone mineral density (BMD) loss greater than or equal to 8 percent in the spine, femoral neck or total hip
* Plans to become pregnant in the next 18 months

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
27/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/05/2017
Sample size
Target
Accrual to date
Final
496
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
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02143713