Elagolix

Generic Name: Elagolix

Brand Names: Oriahnn 28 Day Kit, Orilissa

Drug Type: Small Molecule

Chemical Formula: C_₃₂H_₃₀F_₅N_₃O_₅

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: -

Clinical Trials

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

Phase 3

Completed

Conditions: Endometriosis

Interventions: Other: placebo
Drug: elagolix

First Posted Date: 2012-06-15

Last Posted Date: 2018-09-18

Lead Sponsor: AbbVie (prior sponsor, Abbott)

Target Recruit Count: 872

Registration Number: NCT01620528

Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids

Phase 2

Completed

Conditions: Heavy Uterine Bleeding
Uterine Fibroids

Interventions: Drug: Placebo
Drug: Elagolix
Drug: Estradiol/Norethindrone acetate (E2/NETA)
Drug: Estradiol
Drug: Progesterone

First Posted Date: 2011-09-28

Last Posted Date: 2021-07-13

Lead Sponsor: AbbVie (prior sponsor, Abbott)

Target Recruit Count: 271

Registration Number: NCT01441635

An Open-label Study of the Effects of Elagolix in Adult Premenopausal Females

Phase 1

Completed

Conditions: Folliculogenesis

Interventions: Drug: elagolix

First Posted Date: 2011-07-27

Last Posted Date: 2013-01-08

Lead Sponsor: AbbVie (prior sponsor, Abbott)

Target Recruit Count: 216

Registration Number: NCT01403038

Locations: 🇺🇸
Site Reference ID/Investigator# 50805, Colorado Springs, Colorado, United States
🇺🇸
Site Reference ID/Investigator# 51270, Colorado Springs, Colorado, United States
🇺🇸
Site Reference ID/Investigator# 50884, Denver, Colorado, United States

and more 19 locations

Efficacy and Safety Study of Elagolix in Women With Endometriosis

Phase 2

Completed

Conditions: Endometriosis, Pain

Interventions: Drug: Placebo
Drug: Elagolix

First Posted Date: 2009-09-09

Last Posted Date: 2018-09-26

Lead Sponsor: AbbVie

Target Recruit Count: 137

Registration Number: NCT00973973

Efficacy and Safety Study of Elagolix Versus Placebo or Leuprorelin Acetate in Endometriosis

Phase 2

Completed

Conditions: Endometriosis

Interventions: Drug: Elagolix
Drug: Leuprorelin Acetate Depot
Drug: Placebo to Leuprorelin Acetate
Drug: Placebo to Elagolix

First Posted Date: 2008-11-25

Last Posted Date: 2018-09-10

Lead Sponsor: AbbVie

Target Recruit Count: 174

Registration Number: NCT00797225

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

Phase 2

Completed

Conditions: Endometriosis, Pain

Interventions: Drug: placebo
Drug: Elagolix

First Posted Date: 2008-02-21

Last Posted Date: 2018-09-07

Lead Sponsor: AbbVie

Target Recruit Count: 155

Registration Number: NCT00619866

Elagolix Versus Subcutaneous Depot Medroxyprogesterone Acetate for the Treatment of Endometriosis

Phase 2

Completed

Conditions: Endometriosis

Interventions: Drug: Elagolix
Drug: Subcutaneous depot medroxyprogesterone acetate (DMPA-SC)
Drug: Placebo to DMPA-SC
Drug: Placebo to Elagolix

First Posted Date: 2007-02-21

Last Posted Date: 2018-10-12

Lead Sponsor: AbbVie

Target Recruit Count: 252

Registration Number: NCT00437658

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