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Last Updated: February 26, 2021

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CLINICAL TRIALS PROFILE FOR RELUGOLIX

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All Clinical Trials for 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.
NCT03085095 A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer Recruiting Myovant Sciences GmbH Phase 3 2017-03-03 The purpose of this study is to determine the benefit and safety of relugolix 120 mg once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (<=50 ng/dL [1.7 nmol/L] in patients with androgen-sensitive advanced prostate cancer.
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 Relugolix

Condition Name

Condition Name for Relugolix
Intervention Trials
Uterine Fibroid 3
Heavy Menstrual Bleeding 3
Endometriosis Related Pain 2
Endometriosis 2
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Condition MeSH

Condition MeSH for Relugolix
Intervention Trials
Myofibroma 4
Menorrhagia 4
Leiomyoma 4
Hemorrhage 4
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Clinical Trial Locations for Relugolix

Trials by Country

Trials by Country for Relugolix
Location Trials
United States 19
Japan 1
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Trials by US State

Trials by US State for Relugolix
Location Trials
Florida 5
Arizona 4
Tennessee 3
Ohio 2
Texas 1
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Clinical Trial Progress for Relugolix

Clinical Trial Phase

Clinical Trial Phase for Relugolix
Clinical Trial Phase Trials
Phase 3 9
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for Relugolix
Clinical Trial Phase Trials
Recruiting 6
Enrolling by invitation 3
Not yet recruiting 2
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Clinical Trial Sponsors for Relugolix

Sponsor Name

Sponsor Name for Relugolix
Sponsor Trials
Myovant Sciences GmbH 10
ASKA Pharmaceutical Co., Ltd. 1
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Sponsor Type

Sponsor Type for Relugolix
Sponsor Trials
Industry 11
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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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Mallinckrodt
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Dow
AstraZeneca

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