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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00797225 | Efficacy and Safety Study of Elagolix Versus Placebo or Leuprorelin Acetate in Endometriosis | PHASE2 | COMPLETED | 174 | — | — | Nov 26, 2008 | Feb 24, 2010 | Sep 10, 2018 | - | — |
The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day. The monthly mean NRS is the average of the daily values reported during the 4 weeks prior to each visit.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received placebo tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) for 12 weeks. |
| Elagolix 150 mg | EXPERIMENTAL | Participants received elagolix 150 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg for an additional 12 weeks. |
| Elagolix 250 mg | EXPERIMENTAL | Participants received elagolix 250 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks. |
| Leuprorelin | OTHER | Participants received placebo tablets once a day and leuprorelin acetate 1-month depot 3.75 mg intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Leuprorelin Acetate Depot | DRUG | Leuprorelin acetate depot injection 3.75 mg administered as an intramuscular injection |
| Elagolix | DRUG | Elagolix tablets administered orally |
| Placebo to Elagolix | DRUG | Placebo tablet administered orally |
| Placebo to Leuprorelin Acetate | DRUG | Saline solution administered as an intramuscular injection |
Inclusion Criteria * Female, aged 18 to 45 years, inclusive * Have moderate to severe pelvic pain due to endometriosis * Have been surgically (laparoscopy) diagnosed with endometriosis within the last 5 years and have recurrent or persistent endometriosis symptoms * Have regular menstrual cycle (23...