Estradiol/norethindrone acetate

DRUG14 trials

Conditions

EndometriosisEndometriosis Related PainHealthyHeavy Menstrual BleedingMenopauseUterine FibroidUterine FibroidsUterine Leiomyoma

Phase 1

Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fasting Conditions

CompletedNCT01157182

Teva Pharmaceuticals USAHealthy

Start: 2007-02-28End: 2007-04-30Updated: 2010-12-17

Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fed Conditions

CompletedNCT01181726

Teva Pharmaceuticals USAHealthy

Start: 2007-01-31End: 2007-02-28Updated: 2010-12-08

Phase 3

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

CompletedNCT02654054

AbbVieHeavy Menstrual Bleeding, Uterine Fibroids

Start: 2015-12-22End: 2018-12-12Updated: 2020-06-29

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)

CompletedNCT02691494

AbbVieHeavy Menstrual Bleeding, Uterine Fibroids

Start: 2016-02-03End: 2019-01-23Updated: 2021-07-13

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

CompletedNCT02925494

AbbVieHeavy Menstrual Bleeding, Uterine Fibroids

Start: 2016-09-14End: 2019-03-22Updated: 2021-07-13

LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

CompletedNCT03049735

Myovant Sciences GmbHHeavy Menstrual Bleeding, Uterine Fibroid

Start: 2017-04-26End: 2020-08-24Updated: 2022-04-19

LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

CompletedNCT03103087

Myovant Sciences GmbHHeavy Menstrual Bleeding, Uterine Fibroid

Start: 2017-06-14End: 2020-09-16Updated: 2022-04-20

SPIRIT 1: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain

CompletedNCT03204318

Myovant Sciences GmbHEndometriosis Related Pain

Start: 2017-12-07End: 2021-04-08Updated: 2021-06-28

SPIRIT 2: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain

CompletedNCT03204331

Myovant Sciences GmbHEndometriosis Related Pain

Start: 2017-11-01End: 2021-05-31Updated: 2021-06-28

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

CompletedNCT03213457

AbbVieEndometriosis

Start: 2017-07-07End: 2023-12-06Updated: 2024-12-20

LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

CompletedNCT03412890

Myovant Sciences GmbHHeavy Menstrual Bleeding, Uterine Fibroid

Start: 2017-10-19End: 2021-01-13Updated: 2024-05-09

SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain

CompletedNCT03654274

Myovant Sciences GmbHEndometriosis

Start: 2018-05-22End: 2023-01-31Updated: 2023-08-08

Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

CompletedNCT03751124

Myovant Sciences GmbHUterine Fibroids, Uterine Leiomyoma

Start: 2018-10-16End: 2021-10-20Updated: 2024-06-25

Phase 4

Estrogen Diastolic Heart Failure

TerminatedNCT02693002

Gretchen WellsMenopause

Start: 2016-02-29End: 2016-11-30Updated: 2018-08-08

Fertility and Sterility2025-05-022 citations

A plain language summary describing changes in pain associated with uterine fibroids among women receiving relugolix combination therapy

Pain Management2024-09-01

P-308 Relugolix combination therapy vs relugolix monotherapy with transition to relugolix combination therapy for the treatment of endometriosis-associated pain: implications for cumulative benefit/risk profile

Human Reproduction2024-07-01

Impact of relugolix combination therapy on functioning and quality of life in women with endometriosis-associated pain.

2024-06-196 citations

Impact of demographic and clinical factors on elagolix plus add-back therapy effects on patient-reported nonbleeding symptoms in women with heavy menstrual bleeding and uterine fibroids: a post hoc analysis of data from two clinical trials

F&S Reports2024-06-151 citations

Two-year efficacy and safety of relugolix combination therapy in women with endometriosis-associated pain: SPIRIT open-label extension study

Human Reproduction2024-01-1834 citations

A Plain Language Summary to Learn About Relugolix Combination Therapy for the Treatment of Pain Associated with Endometriosis

Pain Management2023-11-013 citations

Relugolix combination therapy in Black/African American women with symptomatic uterine fibroids: LIBERTY Long-Term Extension study.

2023-10-187 citations

A plain language summary of the long-term relugolix combination therapy study for uterine fibroids

Journal of Comparative Effectiveness Research2023-07-21

Endometriosis Symptoms and Their Impacts on the Daily Lives of US Women: Results from an Interview Study.

2023-06-0110 citations

O-032 Effect of relugolix combination therapy in women with endometriosis-associated pain who received prior first-line hormonal treatment: SPIRIT 1 and 2

Human Reproduction2023-06-01

O-191 Effects of relugolix combination therapy (Relugolix-CT) on uterine fibroid (UF) and uterine volume through 52 weeks: post hoc analysis of the LIBERTY Long-Term Extension study

Human Reproduction2023-06-01

Elagolix With Add-Back Therapy Improves Hemoglobin Concentration in Women With Fibroid-Associated Heavy Menstrual Bleeding Across Subgroups: Post Hoc Analysis of Elaris UF-1 and UF-2 [ID: 1368060]