6 completed, 1 recruiting. 7 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 7 | Completed 6, Recruiting 1 |
Follow Relugolix placebo: new trials by email Literature Review of Relugolix placebo trials Research Report on Relugolix placebo
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Relugolix, Relugolix placebo - Heavy Menstrual Bleeding, Uterine Fibroids | Phase 3 | Recruiting | Qilu Pharmaceutical Co., Ltd. | 120 | 2024-01-15 | 2026-02-02 |
| SPIRIT 1: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain Relugolix, Estradiol/norethindrone acetate, Estradiol/norethindrone acetate placebo - Endometriosis Related Pain | Phase 3 | Completed | Myovant Sciences GmbH | 638 | 2017-12-07 | 2021-06-28 |
| SPIRIT 2: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain Relugolix, Estradiol/norethindrone acetate, Estradiol/norethindrone acetate placebo - Endometriosis Related Pain | Phase 3 | Completed | Myovant Sciences GmbH | 623 | 2017-11-01 | 2021-06-28 |
| LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Relugolix, Estradiol/norethindrone acetate, Relugolix placebo - Heavy Menstrual Bleeding, Uterine Fibroid | Phase 3 | Completed | Myovant Sciences GmbH | 382 | 2017-06-14 | 2022-04-20 |
| LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Relugolix, Estradiol/norethindrone acetate, Estradiol/norethindrone acetate placebo - Heavy Menstrual Bleeding, Uterine Fibroid | Phase 3 | Completed | Myovant Sciences GmbH | 388 | 2017-04-26 | 2022-04-19 |
| A Placebo-Controlled, Phase 3 Study of Relugolix (TAK-385) 40 mg in the Treatment of Pain Symptoms Associated With Uterine Fibroids Relugolix, Relugolix placebo - Uterine Fibroids | Phase 3 | Completed | Takeda | 65 | 2016-03-26 | 2019-03-22 |
| 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 Relugolix, Relugolix Placebo, Leuprorelin - Uterine Fibroids | Phase 3 | Completed | Takeda | 281 | 2016-03-05 | 2019-03-22 |
Leiomyoma (5) · Menorrhagia (3) · Dysmenorrhea (2) · Endometriosis (2) · Pain (2)
Myovant Sciences GmbH (4) · Takeda (2) · Qilu Pharmaceutical Co., Ltd. (1)
Poland (4) · United States (4) · Brazil (3) · Czechia (3) · South Africa (3) · Belgium (2) · Chile (2) · Hungary (2) · Italy (2) · Japan (2) · Argentina (1) · Australia (1) · Bulgaria (1) · Canada (1) · China (1)
PMID 33596357, PMID 35415708, PMID 35675604, PMID 35717987, PMID 36357960, PMID 37183454, PMID 37283994, PMID 37477173, PMID 37863160, PMID 37982388, PMID 39466126, PMID 30741797, PMID 31069056, PMID 31594635, PMID 40320117
2016 (2), 2017 (2)