Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe Pain
Launched by ABBVIE · Apr 2, 2020
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called elagolix, which is taken as a tablet, combined with birth control pills, to see how well it helps women with endometriosis manage their painful periods and overall pain. Endometriosis is a condition where tissue similar to the lining inside the uterus grows outside of it, causing significant pain and affecting daily life. About 800 women who have been diagnosed with endometriosis and experience moderate to severe pain will participate in this study. To be eligible, participants must be women of childbearing age who still have menstrual periods, and they should have a confirmed diagnosis of endometriosis.
During the trial, participants will be randomly assigned to one of three treatment groups: two groups will receive elagolix with birth control pills, and one group will receive a placebo, which does not contain any medication. The study lasts for 18 months, with a focus on monitoring pain levels and any side effects through regular visits to a clinic or hospital. While participants may have a higher treatment burden than their usual care, they will receive close medical supervision, including blood tests and questionnaires to assess their pain and overall health. It's important that participants agree to use non-hormonal contraception during the study and are not pregnant or planning to become pregnant.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Documented surgical confirmation of endometriosis and associated moderate to severe pain.
- • Participants must agree to use dual non-hormonal methods of contraception consistently during washout (if applicable), screening, and 3-month double-blind placebo-controlled treatment periods of the study.
- • Participant, in the investigator's opinion must be an appropriate candidate to receive combined oral contraceptives (COCs).
- Exclusion Criteria:
- • Pregnant or breastfeeding or planning a pregnancy until completion of the study.
- • Surgical history of hysterectomy or bilateral oophorectomy.
- • Participant has osteoporosis or other metabolic bone disease or clinically significant gynecological findings from Screening.
- • Participant has any other active chronic pain condition that would interfere with their assessment of endometriosis-related pain.
About Abbvie
AbbVie is a global biopharmaceutical company dedicated to developing innovative therapies that address complex health challenges. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie focuses on key therapeutic areas, including immunology, oncology, neuroscience, and virology. The company is committed to advancing scientific research and delivering groundbreaking treatments that enhance patient outcomes and quality of life. With a robust pipeline and a strong emphasis on collaboration, AbbVie strives to transform the future of medicine through its commitment to clinical excellence and patient-centered approaches.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Anniston, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Dothan, Alabama, United States
Fairhope, Alabama, United States
Mobile, Alabama, United States
Mobile, Alabama, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Searcy, Arkansas, United States
Encinitas, California, United States
La Palma, California, United States
Northridge, California, United States
Norwalk, California, United States
Sacramento, California, United States
San Diego, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Grand Junction, Colorado, United States
Greenwood Village, Colorado, United States
Lakewood, Colorado, United States
Newark, Delaware, United States
Washington, District Of Columbia, United States
Washington, District Of Columbia, United States
Apopka, Florida, United States
Aventura, Florida, United States
Boynton Beach, Florida, United States
Clearwater, Florida, United States
Clearwater, Florida, United States
Doral, Florida, United States
Doral, Florida, United States
Fort Lauderdale, Florida, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Kissimmee, Florida, United States
Kissimmee, Florida, United States
Margate, Florida, United States
Miami Springs, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miramar, Florida, United States
New Port Richey, Florida, United States
New Port Richey, Florida, United States
North Miami, Florida, United States
Orange City, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Palm Harbor, Florida, United States
Pembroke Pines, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Wellington, Florida, United States
Winter Park, Florida, United States
Alpharetta, Georgia, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
College Park, Georgia, United States
Columbus, Georgia, United States
Columbus, Georgia, United States
Smyrna, Georgia, United States
Snellville, Georgia, United States
Idaho Falls, Idaho, United States
Idaho Falls, Idaho, United States
Meridian, Idaho, United States
Nampa, Idaho, United States
Chicago, Illinois, United States
Oak Brook, Illinois, United States
Park Ridge, Illinois, United States
Avon, Indiana, United States
Brownsburg, Indiana, United States
Fort Wayne, Indiana, United States
Iowa City, Iowa, United States
West Des Moines, Iowa, United States
Shawnee Mission, Kansas, United States
Wichita, Kansas, United States
Wichita, Kansas, United States
Covington, Louisiana, United States
Covington, Louisiana, United States
Eunice, Louisiana, United States
Marrero, Louisiana, United States
Metairie, Louisiana, United States
Shreveport, Louisiana, United States
Frederick, Maryland, United States
Rockville, Maryland, United States
Towson, Maryland, United States
Fall River, Massachusetts, United States
Fall River, Massachusetts, United States
Bay City, Michigan, United States
Saginaw, Michigan, United States
Saint Louis, Missouri, United States
Great Falls, Montana, United States
Missoula, Montana, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
North Las Vegas, Nevada, United States
Camden, New Jersey, United States
Neptune, New Jersey, United States
New Brunswick, New Jersey, United States
Buffalo, New York, United States
East Syracuse, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Staten Island, New York, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
New Bern, North Carolina, United States
Wilmington, North Carolina, United States
Winston Salem, North Carolina, United States
Winston Salem, North Carolina, United States
Winston Salem, North Carolina, United States
Beavercreek, Ohio, United States
Canton, Ohio, United States
Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
Columbus, Ohio, United States
Englewood, Ohio, United States
Fairborn, Ohio, United States
Marion, Ohio, United States
Mayfield Heights, Ohio, United States
Tiffin, Ohio, United States
Frackville, Pennsylvania, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Columbia, South Carolina, United States
Greenville, South Carolina, United States
Greenville, South Carolina, United States
Summerville, South Carolina, United States
West Columbia, South Carolina, United States
Chattanooga, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Friendswood, Texas, United States
Frisco, Texas, United States
Georgetown, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Lampasas, Texas, United States
League City, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Webster, Texas, United States
Draper, Utah, United States
Pleasant Grove, Utah, United States
Salt Lake City, Utah, United States
Newport News, Virginia, United States
North Chesterfield, Virginia, United States
Reston, Virginia, United States
Richmond, Virginia, United States
Richmond, Virginia, United States
Virginia Beach, Virginia, United States
Seattle, Washington, United States
Spokane, Washington, United States
Cidra, , Puerto Rico
San Juan, , Puerto Rico
San Juan, , Puerto Rico
San Diego, California, United States
Dearborn Heights, Michigan, United States
Detroit, Michigan, United States
Little Rock, Arkansas, United States
Miami, Florida, United States
Chicago, Illinois, United States
Brooklyn, New York, United States
Lancaster, California, United States
Pearland, Texas, United States
Miami, Florida, United States
San Diego, California, United States
North Miami Beach, Florida, United States
Kissimmee, Florida, United States
Washington, District Of Columbia, United States
Camden, New Jersey, United States
Pearland, Texas, United States
Apopka, Florida, United States
Detroit, Michigan, United States
Charlotte, North Carolina, United States
Orlando, Florida, United States
West Columbia, South Carolina, United States
Idaho Falls, Idaho, United States
Pleasant Grove, Utah, United States
Oak Brook, Illinois, United States
Fairborn, Ohio, United States
Oak Brook, Illinois, United States
Cincinnati, Ohio, United States
Bay City, Michigan, United States
Chattanooga, Tennessee, United States
New Port Richey, Florida, United States
Chattanooga, Tennessee, United States
Tampa, Florida, United States
Oak Brook, Illinois, United States
Fairborn, Ohio, United States
Summerville, South Carolina, United States
Houston, Texas, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Fairborn, Ohio, United States
Glendale, Arizona, United States
Charlotte, North Carolina, United States
Wilmington, North Carolina, United States
Cincinnati, Ohio, United States
Patients applied
Trial Officials
ABBVIE INC.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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