Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Relugolix · 2 trials · 1 indication
Pain symptoms were evaluated using the NRS score. NRS score is a self-reported instrument assessing pain from 0 to 10. Higher scores reflect greater level of pain. The percentage of participants with a score of 1 or less is reported.
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 tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix 40 mg, tablet, orally once daily before breakfast for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix placebo-matching tablet, orally once daily before breakfast for 12 weeks. |
| 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. |
| 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 |
Inclusion Criteria: Inclusion Criteria for Entering the Screening Period (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 ...