Endometriosis, PainPhase 2NCT00619866

An Efficacy and Safety Study of Elagolix (NBI-56418) in Women With Endometriosis

A Phase 2 study testing Elagolix in people with Endometriosis, Pain, run by AbbVie.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is designed to see how elagolix works compared to placebo in women with endometriosis and to see the effect, if any, on bone mineral density. Read more about this study

Who is it for?: Ages 18 to 49 years, women only
Conditions the study is for: Endometriosis, Pain
What is being tested?: Elagolix
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 155 participants
Where: No sites listed yet
Study dates: 19 Feb 2008to 28 Aug 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 49 years
Women only
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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

About this study

Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-56418 in Subjects With Endometriosis

This study is designed to see how elagolix works compared to placebo in women with endometriosis and to see the effect, if any, on bone mineral density.

Read the detailed description

This is a Phase II, multicenter, randomized, double-blind, placebo-controlled parallel-group study to assess the efficacy and safety of elagolix at two dose levels administered once daily for up to 6 months. Participants will be randomized (1:1:1) to one of the following treatment groups for the first 12 weeks of dosing: 150 mg elagolix once daily (QD); 250 mg elagolix QD or placebo QD. Following 12 weeks of dosing, participants will continue in the study for an additional 12 weeks; participants randomized to elagolix will continue to receive their assigned dose and participants randomized to placebo will be re-randomized to receive one of the two doses of elagolix for 12 weeks in a double-blind fashion. Six weeks after the last dose of study drug at the end of Week 24, a follow-up visit will be performed (end of Week 30).

Conditions: Endometriosis, Pain
Being tested: Elagolix, placebo
Keywords: bone mineral density, Pelvic Pain, estradiol, NBI-56418
Medical subject headings: Endometriosis, Pain, Pelvic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ElagolixDrug
Also called NBI-56418, Orilissa™
Elagolix tablets administered orally
placeboDrug
Placebo tablet administered orally

Study groups in NCT00619866
Study group	Role	What they receive
Placebo	Placebo comparator	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. Receives: Drug: placebo
Elagolix 150 mg	Experimental	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. Receives: Drug: Elagolix
Elagolix 250 mg	Experimental	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. Receives: Drug: Elagolix

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain at 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.
Measured: Baseline and week 12

Secondary outcomes (25)

Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain
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.
Measured: Baseline and weeks 4 and 8
Change From Baseline in the Monthly Peak Numerical Rating Score (NRS) for Endometriosis Pain
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.
Measured: Baseline and Weeks 4, 8, and 12
Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score
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:
- 0 = No pelvic pain
- 1 = Mild pelvic pain; subject could not do some of the things she usually does
- 2 = Moderate pelvic pain; subject could not do many of the things she usually does
- 3 = Severe pelvic pain; subject could not do most or all of the things she usually does.
The monthly mean non-menstrual pelvic pain score is the average of the daily values reported during the 4 weeks prior to each visit.
Measured: Baseline and weeks 4, 8, and 12
Change From Baseline in the Monthly Mean Dysmenorrhea Score
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:
- Subject is not having her period
- 0 = No pain related to period
- 1 = Mild pain related to period; subject could not do some of the things she usually does
- 2 = Moderate pain related to period; subject could not do many of the things she usually does
- 3 = Severe pain related to period; subject could not do most of or all of the things she usually does.
The monthly mean dysmenorrhea score is the average of the daily values reported during the 4 weeks prior to each visit.
Measured: Baseline and Weeks 4, 8, and 12
Change From Baseline in the Monthly Mean Total of Dysmenorrhea and Non-menstrual Pelvic Pain Scores
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.
Measured: Baseline and Weeks 4, 8, and 12
Percentage of Days With No Pain Based on NRS
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.
Measured: Baseline and weeks 4, 8 and 12
Percentage of Days With No Pain Based Based on Non-menstrual Pelvic Pain Daily Assessment
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:
- 0 = No pelvic pain
- 1 = Mild pelvic pain; subject could not do some of the things she usually does
- 2 = Moderate pelvic pain; subject could not do many of the things she usually does
- 3 = Severe pelvic pain; subject could not do most or all of the things she usually does.
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.
Measured: Baseline and weeks 4, 8 and 12
Percentage of Days With No Pain Based Based on Dysmenorrhea Daily Assessment
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:
- Subject is not having her period
- 0 = No pain related to period
- 1 = Mild pain related to period; subject could not do some of the things she usually does
- 2 = Moderate pain related to period; subject could not do many of the things she usually does
- = Severe pain related to period; subject could not do most of or all of the things she usually does.
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.
Measured: 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
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.
Measured: Baseline and weeks 4, 8 and 12
Change From Baseline in the Percentage of Days of Any Analgesic Use
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").
Measured: Baseline and Weeks 4, 8, and 12
Change From Baseline in the Percentage of Days of Prescription Analgesic Use
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").
Measured: Baseline and Weeks 4, 8, and 12
Change From Baseline in the Percentage of Days of Narcotic Analgesic Use
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").
Measured: Baseline and Weeks 4, 8, and 12
Percentage of Participants With 30% Decrease From Baseline in Monthly Mean NRS
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.
Measured: Baseline and weeks 4, 8 and 12
Percentage of Participants With 30% Decrease From Baseline in Monthly Peak NRS
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.
Measured: Baseline and weeks 4, 8 and 12
Percentage of Participants With 50% Decrease From Baseline in Monthly Mean NRS
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.
Measured: Baseline and weeks 4, 8 and 12
Percentage of Participants With 50% Decrease From Baseline in Monthly Peak NRS
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.
Measured: Baseline and weeks 4, 8 and 12
Change From Baseline in Dyspareunia Component of the Composite Pelvic Signs and Symptoms Score (CPSSS)
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:
- 0 = Absent; No discomfort during sexual intercourse.
- 1 = Mild; I can tolerate the discomfort during sexual intercourse.
- 2 = Moderate; Intercourse is sometime interrupted due to pain.
- 3 = Severe; I prefer to avoid intercourse because of pain.
- Not applicable. I am not sexually active for reasons other than my endometriosis symptoms.
Measured: Baseline and Weeks 4, 8, and 12
Patient Global Impression of Change at 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:
1. Very Much Improved
2. Much Improved
3. Minimally Improved
4. Not Changed
5. Minimally Worse
6. Much Worse
7. Very Much Worse
Measured: Weeks 4, 8, and 12
Percentage of Participants With a PGIC Response of Minimally Improved, Much Improved, or Very Much Improved
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:
1. Very Much Improved
2. Much Improved
3. Minimally Improved
4. Not Changed
5. Minimally Worse
6. Much Worse
7. Very Much Worse
Measured: Weeks 4, 8, and 12
Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved
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:
1. Very Much Improved
2. Much Improved
3. Minimally Improved
4. Not Changed
5. Minimally Worse
6. Much Worse
7. Very Much Worse
Measured: Weeks 4, 8, and 12
Change From Baseline in Endometriosis Health Profile-5 (EHP-5) at 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:
- A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image with five response categories for each item (Never, Rarely, Sometimes, Often, Always)
- A supplemental questionnaire consisting of six additional questions which assess the areas of work, relationship with children, sexual intercourse, feelings about the medical profession, treatment, and infertility with the same five response categories plus an additional response category of Not Relevant which was not scored.
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.
Measured: Baseline and week 12
Percent Change From Baseline in Bone Mineral Density of the Femur at Week 12
Bone mineral density (BMD) of the femur (total hip) was measured by dual-energy X-ray absorptiometry (DXA).
Measured: Baseline and week 12
Percent Change From Baseline in Bone Mineral Density of the Femur at Week 24
Bone mineral density (BMD) of the femur (total hip) was measured by dual-energy X-ray absorptiometry (DXA).
Measured: Baseline and Week 24
Percent Change From Baseline in Bone Mineral Density of the Spine at Week 12
Bone mineral density (BMD) of the spine was measured by dual-energy X-ray absorptiometry (DXA).
Measured: Baseline and week 12
Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24
Bone mineral density (BMD) of the spine was measured by dual-energy X-ray absorptiometry (DXA).
Measured: Baseline and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Feb 200828 Aug 2009

First posted21 Feb 2008 (estimated)
Study start19 Feb 2008
Primary completion20 Apr 2009
Study completion28 Aug 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Endometriosis, PainStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 155 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00619866
Sponsor's protocol ID: NBI-56418-0702
Status last verified: Mar 2018
First submitted: 24 Jan 2008
Last updated: 7 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Recruiting
Evaluating the Feasibility of elleFA App Implementation
Endometriosis
Recruiting
Impact of Food Supplementation on Quality of Life in Patients With Endometriosis and Pelvic Pain.
Endometriosis (Diagnosis)
RecruitingObservational study
Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
Endometriosis

All Endometriosis, Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-56418 in Subjects With Endometriosis
ClinicalTrials.gov ID: NCT00619866
Acronym / sponsor ID: NBI-56418-0702
Conditions: Endometriosis, Pain
Keywords: bone mineral density, Pelvic Pain, estradiol, NBI-56418
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 155 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 19 Feb 2008 (actual)
Primary completion: 20 Apr 2009 (actual)
Study completion: 28 Aug 2009 (actual)
First posted: 21 Feb 2008 (estimated)
Results: Posted 7 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is designed to see how elagolix works compared to placebo in women with endometriosis and to see the effect, if any, on bone mineral density.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: placeboParticipants 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.
Elagolix 150 mg	Experimental	Drug: ElagolixParticipants 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 250 mg	Experimental	Drug: ElagolixParticipants 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.

Who may qualify

Ages: 18 to 49 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ElagolixAlso: NBI-56418, Orilissa™Elagolix tablets administered orally	Drug	Elagolix 150 mg, Elagolix 250 mg
placeboPlacebo tablet administered orally	Drug	Placebo

Primary outcome

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.

25 secondary outcomes

Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain
Time frame: Baseline and weeks 4 and 8
Change From Baseline in the Monthly Peak Numerical Rating Score (NRS) for Endometriosis Pain
Time frame: Baseline and Weeks 4, 8, and 12
Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score
Time frame: 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
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
Percentage of Days With No Pain Based on NRS
Time frame: 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
Percentage of Days With No Pain Based Based on Dysmenorrhea Daily Assessment
Time frame: 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
Change From Baseline in the Percentage of Days of Any Analgesic Use
Time frame: 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
Change From Baseline in the Percentage of Days of Narcotic Analgesic Use
Time frame: Baseline and Weeks 4, 8, and 12
Percentage of Participants With 30% Decrease From Baseline in Monthly Mean NRS
Time frame: 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
Percentage of Participants With 50% Decrease From Baseline in Monthly Mean NRS
Time frame: 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
Change From Baseline in Dyspareunia Component of the Composite Pelvic Signs and Symptoms Score (CPSSS)
Time frame: Baseline and Weeks 4, 8, and 12
Patient Global Impression of Change at Weeks 4, 8 and 12
Time frame: Weeks 4, 8, and 12
Percentage of Participants With a PGIC Response of Minimally Improved, Much Improved, or Very Much Improved
Time frame: 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
Change From Baseline in Endometriosis Health Profile-5 (EHP-5) at Week 12
Time frame: Baseline and week 12
Percent Change From Baseline in Bone Mineral Density of the Femur at Week 12
Time frame: Baseline and week 12
Percent Change From Baseline in Bone Mineral Density of the Femur at Week 24
Time frame: Baseline and Week 24
Percent Change From Baseline in Bone Mineral Density of the Spine at Week 12
Time frame: Baseline and week 12
Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24
Time frame: Baseline and Week 24

Results and safety

Results posted to the registry on 7 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	52	38
Elagolix 150 mg	51	45
Elagolix 250 mg	52	42
Placebo / Elagolix 150 mg	0	0
Placebo / Elagolix 250 mg	0	0

Primary outcome: Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain at Week 12

Time frame: Baseline and week 12. Least squares mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 38	Elagolix 150 mg n = 44	Elagolix 250 mg n = 45
Value	-0.88 (0.18)	-1.19 (0.18)	-1.25 (0.18)

Placebo vs Elagolix 150 mg: LS Mean Difference: -0.31 (95% CI -0.81 to 0.20), p = 0.2311, Repeated Measures Analysis of Covariance
Placebo vs Elagolix 250 mg: LS Mean Difference: -0.36 (95% CI -0.86 to 0.14), p = 0.1521, Repeated Measures Analysis of Covariance

Population analysed: All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.

25 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first dose of any study drug through week 24. The Placebo treatment group includes data for the initial 12-week treatment phase. The Elagolix treatment groups include data for the total 24-week treatment period for participants initially randomized to elagolix, and 12-week treatment period for participants initially randomized to placebo and re-randomized at week 12.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 52 (0%)	18 of 52 (34.6%)	0 of 52
Elagolix 150 mg	0 of 69 (0%)	31 of 69 (44.9%)	0 of 69
Elagolix 250 mg	1 of 72 (1.4%)	33 of 72 (45.8%)	0 of 72

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AbbVie Inc. study director

AbbVie

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Elagolix in people with Endometriosis, Pain, run by AbbVie.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain at Week 12 (time frame: Baseline and week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00619866.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.