Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT02655224 | Leiomyoma | Percentage of Participants With a Maximum NRS Score of 1 or Less During the 28 Days Before the Final Dose of Study Drug For 28 days before the final dose of study drug (up to Week 12) | Placebo | 3.1 percentage of participants |
| Relugolix 40 mg | 57.6 percentage of participants | |||
| NCT02655237 | Leiomyoma | Percentage of Participants With Total PBAC Score of <10 From Week 6 to 12 Week 6 to 12 | Leuprorelin 1.88 mg or 3.75 mg | 83.1 percentage of participants |
| Relugolix 40 mg | 82.2 percentage of participants | |||
| NCT03049735 | Leiomyoma | Percentage Of Participants Who Achieved A Menstrual Blood Loss (MBL) Volume Of < 80 mL And A ≥ 50% Reduction From Baseline MBL Volume With Relugolix Plus E2/NETA From Baseline up to last 35 days of treatment (up to Week 24) | Placebo (Group C) | 18.9 Percentage of participants |
| Relugolix Plus E2/NETA (Group A) | 73.4 Percentage of participants | |||
| NCT03085095 HERO | Prostatic Neoplasms | Sustained Castration Rate From Week 5 Day 1 (Day 29) to Week 49 Day 1 (Day 337) | Leuprolide Acetate | 88.8 percentage of participants |
| Relugolix | 96.7 percentage of participants | |||
| NCT03103087 | Leiomyoma | Percentage Of Participants Who Achieved A Menstrual Blood Loss (MBL) Volume Of < 80 mL And A ≥ 50% Reduction From Baseline MBL Volume With Relugolix Plus E2/NETA From Baseline up to the last 35 days of treatment (up to Week 24) | Placebo (Group C) | 14.73 Percentage of participants |
| Relugolix Plus E2/NETA (Group A) | 71.2 Percentage of participants | |||
| NCT03412890 | Leiomyoma | Percentage Of Participants Who Achieved Or Maintained An MBL Volume Of <80 Milliliters (mL) And At Least A 50% Reduction From Baseline MBL Volume At Week 52/End Of Treatment Week 52/End of Treatment | Placebo (Group C) | 75.00 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | 79.87 percentage of participants | |||
| Relugolix Plus E2/NETA (Group A) | 86.50 percentage of participants | |||
| NCT03654274 | Endometriosis | Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 104 Week 104 | Placebo (Group C) | 80.4 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | 83.0 percentage of participants | |||
| Relugolix Plus E2/NETA (Group A) | 84.8 percentage of participants | |||
| NCT03654274 | Endometriosis | Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 52 Week 52 | Placebo (Group C) | 75.6 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | 82.2 percentage of participants | |||
| Relugolix Plus E2/NETA (Group A) | 84.8 percentage of participants | |||
| NCT03654274 | Endometriosis | Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 104 Week 104 | Placebo (Group C) | 73.1 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | 71.7 percentage of participants | |||
| Relugolix Plus E2/NETA (Group A) | 75.8 percentage of participants | |||
| NCT03654274 | Endometriosis | Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 52 Week 52 | Placebo (Group C) | 68.0 percentage of participants |
| Relugolix Plus Delayed E2/NETA (Group B) | 70.4 percentage of participants | |||
| Relugolix Plus E2/NETA (Group A) | 73.6 percentage of participants | |||
| NCT03751124 | Leiomyoma | Percentage Of Participants Who Maintained MBL Volume Of <80 Milliliters (mL) At Week 76 During The Randomized Treatment Period Week 52/Baseline up to Week 76 | Placebo (Group B) | 15.08 percentage of participants |
| Relugolix Plus E2/NETA (Group A) | 78.43 percentage of participants |