- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00619866
An Efficacy and Safety Study of Elagolix (NBI-56418) in Women With Endometriosis
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-56418 in Subjects With Endometriosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Be female, aged 18 to 49 years, inclusive
- Have moderate to severe pelvic pain due to endometriosis
- Have been surgically (laparoscopy) diagnosed with endometriosis within the last 8 years and have recurrent or persistent endometriosis symptoms
- Have regular menstrual cycle
- Have a body mass index (BMI) of 18 to 36 kg/m², inclusive
- Agree to use two forms of non-hormonal contraception during the study
Exclusion Criteria:
- Are currently receiving gonadotropin-releasing hormone (GnRH) agonist or GnRH antagonist or have received any of these agents within 6 months of the start of screening
- Are currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or intramuscular medroxyprogesterone acetate (DMPA-IM) or have received any of these agents within 3 months of the start of screening
- Are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within the last month
- Have had surgery for endometriosis within the last month
- Have had a hysterectomy or bilateral oophorectomy
- Are using systemic steroids on a chronic or regular basis within 3 months
- Have uterine fibroids ≥ 3 cm in diameter
- Have pelvic pain that is not caused by endometriosis
- Have unstable medical condition or chronic disease
- Have been pregnant within the last six months
- Currently breast feeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Participants received placebo tablets once a day for 12 weeks.
At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.
|
Placebo tablet administered orally
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Experimental: Elagolix 150 mg
Participants received elagolix 150 mg tablets once a day for 12 weeks.
At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.
|
Elagolix tablets administered orally
Other Names:
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Experimental: Elagolix 250 mg
Participants received elagolix 250 mg tablets once a day for 12 weeks.
At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.
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Elagolix tablets administered orally
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain at Week 12
Time Frame: Baseline and week 12
|
The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day. The monthly mean NRS is the average of the daily values reported during the 4 weeks prior to each visit. |
Baseline and week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in the Monthly Peak Numerical Rating Score (NRS) for Endometriosis Pain
Time Frame: Baseline and Weeks 4, 8, and 12
|
The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day. The monthly peak NRS is the maximum of the daily values reported during the 4 weeks prior to each visit. |
Baseline and Weeks 4, 8, and 12
|
Change From Baseline in Endometriosis Health Profile-5 (EHP-5) at Week 12
Time Frame: Baseline and week 12
|
The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:
The scores associated with each possible outcome category are as follows: never (0), rarely (25), sometimes (50), often (75), and always (100). A negative change from baseline score indicates improvement in quality of life. |
Baseline and week 12
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Percent Change From Baseline in Bone Mineral Density of the Femur at Week 12
Time Frame: Baseline and week 12
|
Bone mineral density (BMD) of the femur (total hip) was measured by dual-energy X-ray absorptiometry (DXA).
|
Baseline and week 12
|
Percent Change From Baseline in Bone Mineral Density of the Spine at Week 12
Time Frame: Baseline and week 12
|
Bone mineral density (BMD) of the spine was measured by dual-energy X-ray absorptiometry (DXA).
|
Baseline and week 12
|
Percent Change From Baseline in Bone Mineral Density of the Femur at Week 24
Time Frame: Baseline and Week 24
|
Bone mineral density (BMD) of the femur (total hip) was measured by dual-energy X-ray absorptiometry (DXA).
|
Baseline and Week 24
|
Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24
Time Frame: Baseline and Week 24
|
Bone mineral density (BMD) of the spine was measured by dual-energy X-ray absorptiometry (DXA).
|
Baseline and Week 24
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Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain
Time Frame: Baseline and weeks 4 and 8
|
The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day. The monthly mean NRS is the average of the daily values reported during the 4 weeks prior to each visit. |
Baseline and weeks 4 and 8
|
Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score
Time Frame: Baseline and weeks 4, 8, and 12
|
Participants assessed their pelvic pain not related to menses and its impact on their daily activities at approximately the same time every day in an e-Diary according to the following response options:
The monthly mean non-menstrual pelvic pain score is the average of the daily values reported during the 4 weeks prior to each visit. |
Baseline and weeks 4, 8, and 12
|
Change From Baseline in the Monthly Mean Dysmenorrhea Score
Time Frame: Baseline and Weeks 4, 8, and 12
|
Participants assessed dysmenorrhea (pain during menstruation) and its impact on their daily activities at approximately the same time each day in an e-Diary according to the following response options:
The monthly mean dysmenorrhea score is the average of the daily values reported during the 4 weeks prior to each visit. |
Baseline and Weeks 4, 8, and 12
|
Change From Baseline in the Monthly Mean Total of Dysmenorrhea and Non-menstrual Pelvic Pain Scores
Time Frame: Baseline and Weeks 4, 8, and 12
|
Participants assessed dysmenorrhea and pelvic pain not related to menses and their impact on daily activities at approximately the same time every day on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe) in an e-Diary. The sum of the dysmenorrhea and non-menstrual pelvic pain scores on each day were calculated to create a daily total score. On days the participant was not having her period, the dysmenorrhea score was not defined; hence, the total score was equal to the non-menstrual pelvic pain score (range 0 to 3). On days where the participant recorded menstruation the total score ranged from 0 to 6, where higher scores indicate more severe pain. The monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores is the average of the daily values reported during the 4 weeks prior to each visit. |
Baseline and Weeks 4, 8, and 12
|
Percentage of Days With No Pain Based on NRS
Time Frame: Baseline and weeks 4, 8 and 12
|
The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day. The percentage of days a participant reported a value of zero (or "no pain") for the NRS was calculated for the 4 weeks prior to each visit. |
Baseline and weeks 4, 8 and 12
|
Percentage of Days With No Pain Based Based on Non-menstrual Pelvic Pain Daily Assessment
Time Frame: Baseline and weeks 4, 8 and 12
|
Participants assessed their pelvic pain not related to menses and its impact on their daily activities at approximately the same time every day in an e-Diary according to the following response options:
The percentage of days a participant reported a value of zero ("no pain") for non-menstrual pelvic pain was calculated for the 4 weeks prior to each visit. |
Baseline and weeks 4, 8 and 12
|
Percentage of Days With No Pain Based Based on Dysmenorrhea Daily Assessment
Time Frame: Baseline and weeks 4, 8 and 12
|
Participants assessed dysmenorrhea (pain during menstruation) and its impact on their daily activities at approximately the same time each day in an e-Diary according to the following response options:
The percentage of days a participant reported a value of zero ("no pain") for dysmenorrhea was calculated for the 4 weeks prior to each visit. |
Baseline and weeks 4, 8 and 12
|
Percentage of Days With No Pain Based Based on Total Score of Non-menstrual Pelvic Pain and Dysmenorrhea Daily Assessment
Time Frame: Baseline and weeks 4, 8 and 12
|
Participants assessed dysmenorrhea and pelvic pain not related to menses and their impact on daily activities at approximately the same time every day in an e-Diary on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe). The sum of the dysmenorrhea and non-menstrual pelvic pain scores on each day were calculated to create a daily total score. On days the participant was not having her period, the dysmenorrhea score was not defined; hence, the total score was equal to the non-menstrual pelvic pain score (range 0 to 3). On days where the participant recorded menstruation the total score ranged from 0 to 6, where higher scores indicate more severe pain. The percentage of days a participant reported a value of zero ("no pain") for the non-menstrual pelvic pain and dysmenorrhea total score was calculated for the 4 weeks prior to each visit. |
Baseline and weeks 4, 8 and 12
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Change From Baseline in the Percentage of Days of Any Analgesic Use
Time Frame: Baseline and Weeks 4, 8, and 12
|
The daily use of endometriosis analgesics was reported by participants daily using the e-Diary. Participants reported whether the medication was over-the-counter (OTC) or prescription, and, if prescription, whether the medication was a narcotic. The percentage of days of any analgesic use is defined as the number of days in the 4 weeks prior to each study visit that the participant reported the use of an analgesic, divided by the number of study days in the interval that the participant provided an e-Diary report regarding the use of endometriosis analgesics (including a response of "none"). |
Baseline and Weeks 4, 8, and 12
|
Change From Baseline in the Percentage of Days of Prescription Analgesic Use
Time Frame: Baseline and Weeks 4, 8, and 12
|
The daily use of endometriosis analgesics was reported by participants daily using the e-Diary. Participants reported whether the medication was over-the-counter (OTC) or prescription, and, if prescription, whether the medication was a narcotic. The percentage of days of prescription analgesic use is defined as the number of days in the 4 weeks prior to each study visit that the participant reported the use of a prescription analgesic, divided by the number of study days in the interval that the participant provided an e-Diary report regarding the use of endometriosis analgesics (including a response of "none"). |
Baseline and Weeks 4, 8, and 12
|
Change From Baseline in the Percentage of Days of Narcotic Analgesic Use
Time Frame: Baseline and Weeks 4, 8, and 12
|
The daily use of endometriosis analgesics was reported by participants daily using the e-Diary. Participants reported whether the medication was over-the-counter (OTC) or prescription, and, if prescription, whether the medication was a narcotic. The percentage of days of narcotic analgesic use is defined as the number of days in the 4 weeks prior to each study visit that the participant reported the use of a narcotic analgesic, divided by the number of study days in the interval that the participant provided an e-Diary report regarding the use of endometriosis analgesics (including a response of "none"). |
Baseline and Weeks 4, 8, and 12
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Percentage of Participants With 30% Decrease From Baseline in Monthly Mean NRS
Time Frame: Baseline and weeks 4, 8 and 12
|
The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day. The monthly mean NRS is the average of the daily values reported during the 4 weeks prior to each visit. |
Baseline and weeks 4, 8 and 12
|
Percentage of Participants With 30% Decrease From Baseline in Monthly Peak NRS
Time Frame: Baseline and weeks 4, 8 and 12
|
The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day. The monthly peak NRS is the maximum of the daily values reported during the 4 weeks prior to each visit. |
Baseline and weeks 4, 8 and 12
|
Percentage of Participants With 50% Decrease From Baseline in Monthly Mean NRS
Time Frame: Baseline and weeks 4, 8 and 12
|
The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day. The monthly mean NRS is the average of the daily values reported during the 4 weeks prior to each visit. |
Baseline and weeks 4, 8 and 12
|
Percentage of Participants With 50% Decrease From Baseline in Monthly Peak NRS
Time Frame: Baseline and weeks 4, 8 and 12
|
The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day. The monthly peak NRS is the maximum of the daily values reported during the 4 weeks prior to each visit. |
Baseline and weeks 4, 8 and 12
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Change From Baseline in Dyspareunia Component of the Composite Pelvic Signs and Symptoms Score (CPSSS)
Time Frame: Baseline and Weeks 4, 8, and 12
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The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. To assess dyspareunia (painful intercourse) participants were asked to select the best description of pain during sexual intercourse over the past 28 days using the following response categories:
|
Baseline and Weeks 4, 8, and 12
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Patient Global Impression of Change at Weeks 4, 8 and 12
Time Frame: Weeks 4, 8, and 12
|
The Patient Global Impression of Change (PGIC) is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories:
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Weeks 4, 8, and 12
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Percentage of Participants With a PGIC Response of Minimally Improved, Much Improved, or Very Much Improved
Time Frame: Weeks 4, 8, and 12
|
The Patient Global Impression of Change (PGIC) is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories:
|
Weeks 4, 8, and 12
|
Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved
Time Frame: Weeks 4, 8, and 12
|
The Patient Global Impression of Change (PGIC) is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories:
|
Weeks 4, 8, and 12
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NBI-56418-0702
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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