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