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Last Updated: November 4, 2024

CLINICAL TRIALS PROFILE FOR ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX


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All Clinical Trials for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03049735 ↗ LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Completed Myovant Sciences GmbH Phase 3 2017-04-26 The purpose of this study is to determine the benefit of relugolix 40 milligrams (mg) once a day co-administered with estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids.
NCT03103087 ↗ LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Completed Myovant Sciences GmbH Phase 3 2017-06-14 The purpose of this study is to determine the benefit of relugolix 40 milligrams (mg) once a day co-administered with estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids.
NCT03204318 ↗ SPIRIT 1: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain Completed Myovant Sciences GmbH Phase 3 2017-12-07 The purpose of this study is to determine the benefit and safety of relugolix 40 milligrams (mg) once daily, co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) compared with placebo for 24 weeks, on dysmenorrhea and on nonmenstrual pelvic pain.
NCT03204331 ↗ SPIRIT 2: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain Completed Myovant Sciences GmbH Phase 3 2017-11-01 The purpose of this study is to determine the benefit and safety of relugolix 40 milligrams (mg) once daily, co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) compared with placebo for 24 weeks, on dysmenorrhea and on nonmenstrual pelvic pain.
NCT03412890 ↗ LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Completed Myovant Sciences GmbH Phase 3 2017-10-19 The purpose of this study is to determine the long-term efficacy and safety of relugolix 40 milligrams (mg) once daily co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) for 28 weeks on heavy menstrual bleeding associated with uterine fibroids in participants who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3001 or MVT-601-3002).
NCT03654274 ↗ SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain Active, not recruiting Myovant Sciences GmbH Phase 3 2018-05-22 The purpose of this study is to evaluate the long-term efficacy and safety of relugolix 40 milligram (mg) once daily co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) for up to 104 weeks on endometriosis-associated pain in participants who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3101 or MVT-601-3102).
NCT03751124 ↗ Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Active, not recruiting Myovant Sciences GmbH Phase 3 2018-10-16 The objectives of this randomized withdrawal study are to evaluate the long-term efficacy and safety of the combination of relugolix, estradiol (E2) and norethindrone acetate (NETA), once daily, for up to 104 weeks in patients with uterine fibroids who have completed a total of 52 weeks of treatment, including a 24-week treatment period in a parent study (study MVT-601-3001 or MVT-601-3002) and a 28-week treatment period in the open-label extension study (MVT-601-3003), and who meet the definition of responder, defined as a patient who demonstrates a menstrual blood loss of < 80 mL and at least a 50% reduction from parent study baseline menstrual blood loss volume on the alkaline hematin analysis of the feminine products returned at Week 48 in the extension study.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

Condition Name

Condition Name for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Intervention Trials
Heavy Menstrual Bleeding 3
Uterine Fibroid 3
Uterine Fibroids 2
Endometriosis 2
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Condition MeSH

Condition MeSH for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Intervention Trials
Leiomyoma 7
Myofibroma 6
Endometriosis 5
Menorrhagia 5
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Clinical Trial Locations for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

Trials by Country

Trials by Country for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Location Trials
United States 193
Poland 37
Hungary 23
South Africa 18
Czechia 15
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Trials by US State

Trials by US State for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Location Trials
Florida 9
Georgia 8
Alabama 8
Virginia 8
Texas 8
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Clinical Trial Progress for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

Clinical Trial Phase

Clinical Trial Phase for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Clinical Trial Phase Trials
Phase 4 1
Phase 3 9
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Clinical Trial Phase Trials
Completed 7
Active, not recruiting 2
Not yet recruiting 2
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Clinical Trial Sponsors for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

Sponsor Name

Sponsor Name for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Sponsor Trials
Myovant Sciences GmbH 12
University of Chicago 1
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Sponsor Type

Sponsor Type for ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Sponsor Trials
Industry 12
Other 1
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