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Last Updated: July 30, 2021

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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 Recruiting Myovant Sciences GmbH Phase 3 2017-01-01 The purpose of this study is to determine the benefit and safety of relugolix 40 mg once daily co-administered with low dose estradiol and norethindrone acetate compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids. Additionally, this study is designed to evaluate the benefit of relugolix 40 mg once daily for 12 weeks followed by 12 weeks of relugolix 40 mg once daily co-administered with low dose estradiol and norethindrone acetate compared with placebo for 24 weeks in the same population.
NCT03103087 ↗ LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Recruiting Myovant Sciences GmbH Phase 3 2017-03-28 The purpose of this study is to determine the benefit and safety of relugolix 40 mg once daily co-administered with low dose estradiol and norethindrone acetate compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids. Additionally, this study is designed to evaluate the benefit of relugolix 40 mg once daily for 12 weeks followed by 12 weeks of relugolix 40 mg once daily co-administered with low dose estradiol and norethindrone acetate compared with placebo for 24 weeks in the same population.
NCT03204318 ↗ SPIRIT 1: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain Recruiting Myovant Sciences GmbH Phase 3 2017-06-27 The purpose of this study is to determine the benefit and safety of relugolix 40 mg once daily, co-administered with low-dose estradiol and norethindrone acetate 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 Recruiting Myovant Sciences GmbH Phase 3 2017-08-30 The purpose of this study is to determine the benefit and safety of relugolix 40 mg once daily, co-administered with low-dose estradiol and norethindrone acetate 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 Enrolling by invitation Myovant Sciences GmbH Phase 3 2017-10-19 The purpose of this study is to determine the long-term efficacy of Relugolix 40 mg once daily co-administered with low-dose estradiol and norethindrone acetate for up to 52 weeks, on heavy menstrual bleeding associated with uterine fibroids in patients 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 Enrolling by invitation Myovant Sciences GmbH Phase 3 2018-05-22 The purpose of this study is to determine the long-term efficacy and safety of relugolix 40 mg once daily co-administered with low-dose estradiol and norethindrone acetate for up to 52 weeks, on endometriosis-associated pain in patients who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3101 or MVT-601-3102).
>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
Endometriosis Related Pain 2
Healthy 1
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Condition MeSH

Condition MeSH for Estradiol; Norethindrone Acetate; Relugolix
Intervention Trials
Myofibroma 4
Menorrhagia 4
Leiomyoma 4
Hemorrhage 4
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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 18
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Trials by US State

Trials by US State for Estradiol; Norethindrone Acetate; Relugolix
Location Trials
Florida 5
Tennessee 3
Arizona 3
Ohio 2
Texas 1
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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 3 8
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Estradiol; Norethindrone Acetate; Relugolix
Clinical Trial Phase Trials
Recruiting 5
Enrolling by invitation 3
Not yet recruiting 1
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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 9
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Sponsor Type

Sponsor Type for Estradiol; Norethindrone Acetate; Relugolix
Sponsor Trials
Industry 9
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