| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04333576 | Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe Pain | PHASE3 | ACTIVE NOT_RECRUITING | 800 | — | — | Aug 10, 2020 | Jun 1, 2030 | Nov 19, 2025 | 179 | United States, Puerto Rico |
| NCT02143713 | Global Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Women With Moderate to Severe Endometriosis-associated Pain | PHASE3 | COMPLETED | 496 | — | — | May 27, 2014 | May 23, 2017 | Jul 13, 2021 | - | — |
| NCT01931670 | A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain | PHASE3 | COMPLETED | 815 | — | — | Sep 9, 2013 | Dec 19, 2016 | Sep 7, 2018 | - | — |
| NCT01760954 | Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Adults With Moderate to Severe Endometriosis-Associated Pain | PHASE3 | COMPLETED | 506 | — | — | Dec 28, 2012 | Apr 15, 2016 | Jul 13, 2021 | - | — |
| NCT01620528 | A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain | PHASE3 | COMPLETED | 872 | — | — | May 22, 2012 | Sep 28, 2015 | Sep 18, 2018 | - | — |
| NCT00437658 | Elagolix Versus Subcutaneous Depot Medroxyprogesterone Acetate for the Treatment of Endometriosis | PHASE2 | COMPLETED | 252 | — | — | Dec 11, 2006 | Nov 24, 2008 | Oct 12, 2018 | - | — |
DYS response is measured by the 4-point Endometriosis Daily Pain Impact Scale (none, mild, moderate, severe) and with stable or decreased analgesic use.
Response was defined as a reduction of -0.85 or more from baseline in dysmenorrhea (pain during menstruation) as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a \< 15% increase in average rescue analgesic pill count and no additional analgesic). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-671. Participants recorded rescue analgesic use for endometriosis-associated pain daily and dysmenorrhea and its impact on daily activities each day of their period in an electronic diary (e-Diary). Dysmenorrhea was assessed according to the following: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3: Severe pain that made it difficult to do the things I usually do. Analgesic use and pain scores were averaged over the 35 days prior to each visit.
Response was defined as a reduction of -0.43 or greater from baseline for non-menstrual pelvic pain as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a \< 15% increase in average pill count of rescue analgesics and no additional analgesics). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-671. Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed non-menstrual pelvic pain and its impact on their daily activities each day in an e-Diary according to the following response options: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3: Severe pain that made it difficult to do the things I usually do. Pain scores and analgesic use were averaged over the 35 days prior to each visit.
The DYS pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain.
The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain.
Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in spine and femur BMD at week 24 was assessed using a one-way analysis of variance (ANOVA) model. The absence of significant bone loss was supported if the lower bounds of the confidence intervals for the mean percent change in BMD were ≥ -2.2% for both the spine and femur at week 24.
Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in spine and femur BMD at week 24 was assessed using a one-way analysis of variance (ANOVA) model. The absence of significant bone loss was supported if the lower bounds of the confidence intervals for the mean percent change in BMD were ≥ -2.2% for both the spine and femur at week 24.
| Arm | Type | Description |
|---|---|---|
| Double-Blind: Placebo | PLACEBO_COMPARATOR | Participants will receive double-blind placebo on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC (combined oral contraceptive) for 15 months. Participants will be followed-up for up to 12 months. |
| Double-Blind: Elagolix | EXPERIMENTAL | Participants will receive double-blind Elagolix on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC (combined oral contraceptive) for 15 months. Participants will be followed-up for up to 12 months. |
| Double-Blind: Elagolix + COC | EXPERIMENTAL | Participants will receive double-blind elagolix in combination with COC (combined oral contraceptive) on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC for 15 months. Participants will be followed-up for up to 12 months. |
| Elagolix 150 mg QD | EXPERIMENTAL | Participants received elagolix 150 mg tablets once a day (QD) for 6 months. |
| Elagolix 200 mg BID | EXPERIMENTAL | Participants received elagolix 200 mg tablets twice a day (BID) for 6 months. |
| Placebo | PLACEBO_COMPARATOR | Placebo twice daily (BID) for the 6-month Treatment Period |
| Elagolix 75 mg BID | EXPERIMENTAL | Participants received elagolix 75 mg orally twice a day (BID) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12. |
| DMPA-SC | ACTIVE_COMPARATOR | Participants received placebo to elagolix orally once a day for 24 weeks and DMPA-SC 104 mg by subcutaneous injection at weeks 1 and 12. |
| Name | Type | Description |
|---|---|---|
| Elagolix | DRUG | Tablet:Oral |
| Placebo | DRUG | Tablet:Oral |
| Combined Oral Contraceptive | DRUG | Tablet:Oral |
| Subcutaneous depot medroxyprogesterone acetate (DMPA-SC) | DRUG | Provided for subcutaneous injection in a prefilled syringe, 104 mg/0.65 mL per syringe. |
| Placebo to Elagolix | DRUG | Matching placebo tablets for oral administration |
| Placebo to DMPA-SC | DRUG | Matching placebo for subcutaneous injection in a pre-filled syringe |
Inclusion Criteria: * Documented surgical confirmation of endometriosis and associated moderate to severe pain. * Participants must agree to use dual non-hormonal methods of contraception consistently during washout (if applicable), screening, and 3-month double-blind placebo-controlled treatment p...