A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain



Status:Terminated
Conditions:Women's Studies, Endometriosis
Therapuetic Areas:Other, Reproductive
Healthy:No
Age Range:18 - 49
Updated:10/10/2018
Start Date:December 27, 2017
End Date:September 4, 2018

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A Study to Evaluate Safety and Efficacy of Elagolix Alone or Elagolix With Hormonal Add-Back in Subjects With Endometriosis With Associated Moderate to Severe Pain

This is a Phase 3, dose-escalation study designed to evaluate the safety and efficacy of both
elagolix alone and elagolix plus Estradiol/Norethindrone acetate (E2/NETA) over 24 months in
the management of endometriosis with associated moderate to severe pain in premenopausal
women.


Inclusion Criteria:

- Participant is a premenopausal female 18 to 49 years of age (inclusive) at the time of
Screening.

- Participant has a documented surgical diagnosis (e.g., laparoscopy or laparotomy) of
endometriosis established by visualization or histology within 10 years prior to entry
into Washout or Screening,

- Participant must agree to use only those rescue analgesics permitted by the protocol
during the Screening and Treatment Periods for her endometriosis-associated pain.

- Participant must have the following documented in the e-Diary during the last 35 days
prior to Study Day 1:

1. At least 2 days of "moderate" or "severe" DYS, AND either,

2. At least 2 days of "moderate" or "severe" NMPP and an average NMPP score of at
least 1.0, OR

3. At least 4 days of "moderate" or "severe" NMPP and an average NMPP score of at
least 0.5.

Exclusion Criteria:

- Participant has chronic pelvic pain that is not caused by endometriosis that requires
chronic analgesic therapy, which would interfere with the assessment of
endometriosis-associated pain.

- Participant is using any systemic corticosteroids for over 14 days within 3 months
prior to Screening or is likely to require treatment with systemic corticosteroids
during the course of the study. Over-the-counter and prescription topical, inhaled or
intranasal corticosteroids are allowed.

- Participant has a history of major depression or post-traumatic stress disorder (PTSD)
within 2 years prior to screening or other major psychiatric disorder at any time

- Participant has a history of suicide attempts or answered "yes" to questions 4 or 5 on
the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS)
at Screening or prior to study drug dosing on Day 1.

- Participant has any condition that would interfere with obtaining adequate DXA
measurements

- Screening DXA results of the lumbar spine (L1 - L4), femoral neck or total hip BMD
corresponding to less than 2 or more standard deviations below normal (Z-score < -2.0
for participants < 40 years of age, T-score for participants >= 40 years of age).

- Participant has either

1. a newly diagnosed, clinically significant medical condition that requires
therapeutic intervention (e.g., new onset hypertension) that has not been
stabilized 30 days prior to enrollment on Day 1 OR

2. a clinically significant medical condition that is anticipated to required
intervention during the course of study participation (e.g., anticipated major
elective surgery) OR

3. an unstable medical condition that makes the participant an unsuitable candidate
for the study in the opinion of the Investigator

- Participant has any conditions contraindicated with use of E2/NETA
We found this trial at
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Chicago, Illinois 60611
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8080 Ravines Edge Court
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Garden Grove, California 92844
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Houston, Texas 77030
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17822 Beach Boulevard
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1550 Elk Creek Drive
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500 South University Avenue
Little Rock, Arkansas 72205
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