A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain



Status:Completed
Conditions:Women's Studies, Endometriosis
Therapuetic Areas:Other, Reproductive
Healthy:No
Age Range:18 - 49
Updated:1/19/2017
Start Date:September 2013
End Date:December 2016

Use our guide to learn which trials are right for you!

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

A randomized study evaluating the safety and efficacy of elagolix in the management of
moderate to severe endometriosis-associated pain in adult premenopausal female subjects.

The study consists of 4 periods: 1) Washout Period (if applicable); 2) a Screening Period of
up to 100 days prior to first dose; 3) a 6 month Treatment Period; and 4) a Post treatment
Follow-up Period of up to 12 months (if applicable). An electronic diary will be dispensed
and training provided to record endometriosis-associated pain, uterine bleeding, and
analgesic medication use for endometriosis-associated pain on a daily basis. Pregnancy
testing will be performed monthly throughout the study. Subjects will be required to use
nonhormonal dual contraception during the study, and will be counseled on appropriate and
effective forms of birth control to promote pregnancy prevention.

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 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.

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.
We found this trial at
141
sites
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Arlington, TX
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Augusta, GA
Click here to add this to my saved trials
?
mi
from
Aventura, FL
Click here to add this to my saved trials
?
mi
from
Bay City, MI
Click here to add this to my saved trials
?
mi
from
Bellaire, TX
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Boise, ID
Click here to add this to my saved trials
?
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
?
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
?
mi
from
Bristol, TN
Click here to add this to my saved trials
?
mi
from
Bristol, TN
Click here to add this to my saved trials
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
?
mi
from
Bryan, TX
Click here to add this to my saved trials
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
?
mi
from
Chino, CA
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
?
mi
from
Columbia, SC
Click here to add this to my saved trials
?
mi
from
Columbus, GA
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Crystal River, FL
Click here to add this to my saved trials
?
mi
from
Cullman, AL
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
?
mi
from
Decatur, GA
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Desoto, TX
Click here to add this to my saved trials
?
mi
from
Doral, FL
Click here to add this to my saved trials
?
mi
from
Draper, UT
Click here to add this to my saved trials
?
mi
from
Evanston, IL
Click here to add this to my saved trials
Fall River, Massachusetts 02720
?
mi
from
Fall River, MA
Click here to add this to my saved trials
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
?
mi
from
Fort Wayne, IN
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
?
mi
from
Frisco, TX
Click here to add this to my saved trials
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
?
mi
from
Granger, IN
Click here to add this to my saved trials
?
mi
from
Gurnee, IL
Click here to add this to my saved trials
?
mi
from
Hershey, PA
Click here to add this to my saved trials
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
High Point, NC
Click here to add this to my saved trials
?
mi
from
Hopwood, PA
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Irving, TX
Click here to add this to my saved trials
?
mi
from
Jackson, TN
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Jersey City, NJ
Click here to add this to my saved trials
?
mi
from
Johnson City, TN
Click here to add this to my saved trials
?
mi
from
Jonesboro, AR
Click here to add this to my saved trials
?
mi
from
Lafayette, IN
Click here to add this to my saved trials
?
mi
from
Lake Worth, FL
Click here to add this to my saved trials
?
mi
from
Lakewood, CO
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
LawrenceVille, New Jersey 08648
?
mi
from
LawrenceVille, NJ
Click here to add this to my saved trials
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
?
mi
from
Levittown, PA
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Metairie, LA
Click here to add this to my saved trials
?
mi
from
Metairie, LA
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami Springs, FL
Click here to add this to my saved trials
?
mi
from
Milford, CT
Click here to add this to my saved trials
?
mi
from
Mineola, NY
Click here to add this to my saved trials
?
mi
from
Mobile, AL
Click here to add this to my saved trials
Myrtle Beach, South Carolina 29572
?
mi
from
Myrtle Beach, SC
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Newark, DE
Click here to add this to my saved trials
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
?
mi
from
Norwalk, CA
Click here to add this to my saved trials
?
mi
from
Oak Brook, IL
Click here to add this to my saved trials
?
mi
from
Oceanside, CA
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials