CLINICAL TRIALS PROFILE FOR RELUGOLIX
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All Clinical Trials for Relugolix
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT02083185 ↗ | A Phase 2 Study to Evaluate the Safety and Efficacy of TAK-385, Together With a Leuprorelin Observational Cohort, in Participants With Prostate Cancer | Completed | Millennium Pharmaceuticals, Inc. | Phase 2 | 2014-03-26 | The purpose of this study is to evaluate the efficacy of TAK 385 for achieving and maintaining testosterone suppression (<50 ng/dL). |
| NCT02655224 ↗ | A Placebo-Controlled, Phase 3 Study of Relugolix (TAK-385) 40 mg in the Treatment of Pain Symptoms Associated With Uterine Fibroids | Completed | Takeda | Phase 3 | 2016-03-26 | The purpose of this study is to evaluate the efficacy and safety of Relugolix (TAK-385) in patients having pain symptoms associated with uterine fibroids. |
| NCT02655237 ↗ | A Phase 3 Study to Evaluate the Efficacy and Safety of Relugolix (TAK-385) 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids | Completed | Takeda | Phase 3 | 2016-03-05 | The purpose of this study is to evaluate the efficacy of Relugolix (TAK-385) 40 mg administered orally once daily for 12 weeks, compared with leuprorelin injection (once every 4 weeks, 1.88 mg or 3.75 mg subcutaneously [SC]/time) in patients with uterine fibroids. |
| 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. |
| NCT03085095 ↗ | A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer | Active, not recruiting | Myovant Sciences GmbH | Phase 3 | 2017-04-18 | The purpose of this study is to determine the efficacy and safety of relugolix 120 milligrams (mg) orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (< 50 nanograms/deciliter [ng/dL]) in participants with androgen-sensitive advanced prostate cancer. |
| 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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