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Leuprorelin Depot · 1 trial · 1 indication
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...
Leuprorelin Depot is used for endometriosis. It is a small molecule being developed by AbbVie Inc. (ABBV) and is currently in Phase 2 clinical development. In a completed clinical trial, it was studied as an active comparator against placebo and elagolix in patients with endometriosis.
Leuprorelin Depot is a small molecule. Its specific molecular target is not disclosed in the available information. It is being studied for its effects in endometriosis, a condition where tissue similar to the uterine lining grows outside the uterus.
Leuprorelin Depot is developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. AbbVie is conducting clinical research on this drug for the treatment of endometriosis.
Leuprorelin Depot is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial involving Leuprorelin Depot has been completed, and the drug is not currently in any active trials.
Leuprorelin Depot was studied in a completed Phase 2 clinical trial with the identifier NCT00797225. The trial, titled 'Efficacy and Safety Study of Elagolix Versus Placebo or Leuprorelin Acetate in Endometriosis,' enrolled 174 female participants aged 18 years and older. The study was randomized, double-blind, and placebo-controlled.