Elagolix

Generic Name
Elagolix
Brand Names
Oriahnn 28 Day Kit, Orilissa
Drug Type
Small Molecule
Chemical Formula
C32H30F5N3O5
CAS Number
834153-87-6
Unique Ingredient Identifier
5B2546MB5Z
Background

Elagolix has been used in trials studying the basic science and treatment of Endometriosis, Folliculogenesis, Uterine Fibroids, Heavy Uterine Bleeding, and Heavy Menstrual Bleeding. As of 24 July 2018, however, the U.S. Food and Drug Administration (FDA) approved AbbVie's elagolix under the brand name Orilissa as the first and only oral gonadotropin-releasin...

Indication

用于治疗子宫内膜异位症并伴有中度至重度疼痛。

Associated Conditions
Heavy Menstrual Bleeding, Moderate to severe pain
Associated Therapies
-

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

First Posted Date
2017-11-17
Last Posted Date
2019-11-27
Lead Sponsor
AbbVie
Target Recruit Count
11
Registration Number
NCT03343067
Locations
🇺🇸

Quad Clinical Research, LLC /ID# 168294, Chicago, Illinois, United States

🇺🇸

Seattle Reproductive Medicine /ID# 171079, Seattle, Washington, United States

🇺🇸

Central Ohio Clinical Research /ID# 170750, Columbus, Ohio, United States

and more 34 locations

Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

First Posted Date
2017-09-05
Last Posted Date
2024-07-19
Lead Sponsor
AbbVie
Target Recruit Count
478
Registration Number
NCT03271489
Locations
🇺🇸

Exordia Medical Research, Inc /ID# 160853, Fall River, Massachusetts, United States

🇺🇸

Health care Affiliates Medical Group /ID# 163324, Santa Ana, California, United States

🇺🇸

Duplicate_Northwell Health System - Manhasset /ID# 201058, Manhasset, New York, United States

and more 154 locations

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

First Posted Date
2017-07-11
Last Posted Date
2024-12-20
Lead Sponsor
AbbVie
Target Recruit Count
681
Registration Number
NCT03213457
Locations
🇺🇸

Clinical Research Adv, Inc. /ID# 149257, Puyallup, Washington, United States

🇺🇸

Tidewater Clinical Research /ID# 145397, Virginia Beach, Virginia, United States

🇺🇸

Atlanta Women's Research Inst /ID# 145543, Atlanta, Georgia, United States

and more 194 locations

An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

First Posted Date
2016-10-06
Last Posted Date
2021-07-13
Lead Sponsor
AbbVie
Target Recruit Count
433
Registration Number
NCT02925494
Locations
🇺🇸

Choice Research, LLC /ID# 153492, Dothan, Alabama, United States

🇺🇸

NECCR Fall River LLC /ID# 153274, Fall River, Massachusetts, United States

🇺🇸

Mount Vernon Clinical Res, LLC /ID# 153403, Atlanta, Georgia, United States

and more 121 locations

Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)

First Posted Date
2016-02-25
Last Posted Date
2021-07-13
Lead Sponsor
AbbVie
Target Recruit Count
378
Registration Number
NCT02691494
Locations
🇺🇸

University of California, Los Angeles /ID# 149760, Los Angeles, California, United States

🇺🇸

Mount Vernon Clinical Res, LLC /ID# 144297, Atlanta, Georgia, United States

🇺🇸

Clinical Trial Investigators /ID# 152470, Tustin, California, United States

and more 102 locations

Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

First Posted Date
2016-01-13
Last Posted Date
2020-06-29
Lead Sponsor
AbbVie
Target Recruit Count
413
Registration Number
NCT02654054
Locations
🇺🇸

Houston Ctr for Clin Research /ID# 149149, Sugar Land, Texas, United States

🇺🇸

Fellows Research Alliance, Inc /ID# 139655, Savannah, Georgia, United States

🇺🇸

University of California, Los Angeles /ID# 144107, Los Angeles, California, United States

and more 93 locations

Global Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Women With Moderate to Severe Endometriosis-associated Pain

Phase 3
Completed
Conditions
Interventions
First Posted Date
2014-05-21
Last Posted Date
2021-07-13
Lead Sponsor
AbbVie
Target Recruit Count
496
Registration Number
NCT02143713

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

Phase 3
Completed
Conditions
Interventions
First Posted Date
2013-08-29
Last Posted Date
2018-09-07
Lead Sponsor
AbbVie
Target Recruit Count
815
Registration Number
NCT01931670

Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Adults With Moderate to Severe Endometriosis-Associated Pain

Phase 3
Completed
Conditions
Interventions
First Posted Date
2013-01-04
Last Posted Date
2021-07-13
Lead Sponsor
AbbVie
Target Recruit Count
506
Registration Number
NCT01760954
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