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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 | >Sponsor | >Phase | >Start Date | >Summary |
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