Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE3 | COMPLETED | 281 | — | — | Mar 5, 2016 | Sep 25, 2017 | Mar 22, 2019 | 25 | Japan |
| NCT00776074 | A Pharmacodynamic Study of Leuprorelin Gelatin-Free Formulation in Female Subjects With Uterine Fibroids. | PHASE2 | COMPLETED | 80 | — | — | Jun 1, 2006 | Jul 1, 2007 | Jun 22, 2010 | - | — |
PBAC score was used to measure volume of menstrual blood loss. Participants used sanitary products designated by sponsor and recorded the numbers of tampons or towels used, clots and flooding in patient diary. Three diagrams used which represented a lightly, moderately stained or completely saturated pad/tampon. Following scores assigned: 1) 1, 5, or 20 points for each pad; 2) 1, 5, or 10 points for each tampon; 3) 1 or 5 points for each blood clot of \<1 cm/=1 cm/\>1 in longest diameter; 4) 5 points for each episode of flooding. The total PBAC score (sum of points) ranges from 0 to \>500.
| Arm | Type | Description |
|---|---|---|
| Relugolix 40 mg | EXPERIMENTAL | Relugolix placebo matching tablets, orally, once daily along with leuprorelin acetate placebo matching injection, SC, once in 4 weeks for 3 to 6 weeks in run-in period followed by relugolix 40 mg, tablets, orally, once daily and leuprorelin acetate placebo matching injection, SC, once in 4 weeks for 24 weeks in treatment period. |
| Leuprorelin 1.88 mg or 3.75 mg | ACTIVE_COMPARATOR | Relugolix placebo matching tablets, orally, once daily along with leuprorelin acetate placebo matching injection, SC, once in 4 weeks for 3 to 6 weeks in run-in period followed by leuprorelin acetate 1.88 mg or 3.75 mg, injection, SC, once in 4 weeks and relugolix placebo matching tablets, orally, once daily for 24 weeks in treatment period. |
| Leuprorelin (GF) | EXPERIMENTAL | - |
| Leuprorelin (GC) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Relugolix | DRUG | Relugolix tablets |
| Relugolix Placebo | DRUG | Relugolix placebo-matching tablets |
| Leuprorelin | DRUG | Leuprorelin injection |
| Leuprorelin Placebo | DRUG | Leuprorelin placebo-matching injections |
| Leuprorelin (GF) | DRUG | Leuprorelin (GF) 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks. |
| Leuprorelin (GC) | DRUG | Leuprorelin (GC) 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks. |
Inclusion Criteria: Inclusion Criteria for Entering the Screening (at VISIT 1) 1. In the opinion of the investigator or subinvestigator, the participant is capable of understanding and complying with protocol requirements. 2. The participant signs and dates a written, informed consent form prior t...