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A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
Phase 3 trial testing elagolix in Endometriosis in 872 participants. Completed in 28 September 2015.
| Lead sponsor | AbbVie (prior sponsor, Abbott) |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 872 |
| Start date | 22 May 2012 |
| Primary completion | 14 November 2014 |
| Estimated completion | 28 September 2015 |
AbbVie (prior sponsor, Abbott) — full company profile →
Adults 18 to 49, female only, with Endometriosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 19.6 | |
| Elagolix 150 mg QD | 46.4 | |
| Elagolix 200 mg BID | 75.8 |
The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 36.5 | |
| Elagolix 150 mg QD | 50.4 | |
| Elagolix 200 mg BID | 54.5 |
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -1.09 | ± 0.098 |
| Elagolix 150 mg QD | -1.74 | ± 0.120 |
| Elagolix 200 mg BID | -2.39 | ± 0.122 |
The DYS pain scale ranges from 0 (none) to 3 (severe).
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -0.44 | ± 0.047 |
| Elagolix 150 mg QD | -0.89 | ± 0.057 |
| Elagolix 200 mg BID | -1.75 | ± 0.059 |
The NMPP pain scale ranges from 0 (none) to 3 (severe).
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -0.31 | ± 0.035 |
| Elagolix 150 mg QD | -0.48 | ± 0.043 |
| Elagolix 200 mg BID | -0.72 | ± 0.044 |
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -0.29 | ± 0.032 |
| Elagolix 150 mg QD | -0.29 | ± 0.039 |
| Elagolix 200 mg BID | -0.55 | ± 0.040 |
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -0.27 | ± 0.036 |
| Elagolix 150 mg QD | -0.35 | ± 0.043 |
| Elagolix 200 mg BID | -0.56 | ± 0.045 |
The DYSP pain scale ranges from 0 (absent) to 3 (severe).
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -0.29 | ± 0.041 |
| Elagolix 150 mg QD | -0.39 | ± 0.050 |
| Elagolix 200 mg BID | -0.49 | ± 0.052 |
Permitted rescue narcotic analgesics included 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -0.10 | ± 0.024 |
| Elagolix 150 mg QD | -0.07 | ± 0.029 |
| Elagolix 200 mg BID | -0.22 | ± 0.029 |
The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 14.5 | |
| Elagolix 150 mg QD | 35.1 | |
| Elagolix 200 mg BID | 44.1 |
The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 17.2 | |
| Elagolix 150 mg QD | 44.8 | |
| Elagolix 200 mg BID | 71.3 |
The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 21.7 | |
| Elagolix 150 mg QD | 47.6 | |
| Elagolix 200 mg BID | 75.3 |
Time frame: From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Placebo | Elagolix 150 MG QD | Elagolix 200 MG BID |
|---|---|---|---|---|
| ENDOMETRIOSIS | Reproductive system and breast disorders | — | — | — |
| CONSTIPATION | Gastrointestinal disorders | — | — | — |
| CHEST PAIN | General disorders | — | — | — |
| APPENDICITIS | Infections and infestations | — | — | — |
| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | — | — | — |
| MENINGITIS VIRAL | Infections and infestations | — | — | — |
| PYELONEPHRITIS | Infections and infestations | — | — | — |
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | — | — | — |
| BLOOD POTASSIUM DECREASED | Investigations | — | — | — |
| RHEUMATOID ARTHRITIS | Musculoskeletal and connective tissue disorders | — | — | — |
| SYNOVITIS | Musculoskeletal and connective tissue disorders | — | — | — |
| ECTOPIC PREGNANCY | Pregnancy, puerperium and perinatal conditions | — | — | — |
| ANXIETY | Psychiatric disorders | — | — | — |
| CALCULUS URETERIC | Renal and urinary disorders | — | — | — |
| HYDRONEPHROSIS | Renal and urinary disorders | — | — | — |
| NEPHROLITHIASIS | Renal and urinary disorders | — | — | — |
| URETERIC STENOSIS | Renal and urinary disorders | — | — | — |
| HAEMORRHAGIC OVARIAN CYST | Reproductive system and breast disorders | — | — | — |
| OVARIAN CYST RUPTURED | Reproductive system and breast disorders | — | — | — |
| PELVIC PAIN | Reproductive system and breast disorders | — | — | — |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | — | — | — |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | — | — | — |
| VICTIM OF SEXUAL ABUSE | Social circumstances | — | — | — |
| DEEP VEIN THROMBOSIS | Vascular disorders | — | — | — |
| Reaction | System | Placebo | Elagolix 150 MG QD | Elagolix 200 MG BID |
|---|---|---|---|---|
| HOT FLUSH | Vascular disorders | — | — | — |
| NAUSEA | Gastrointestinal disorders | — | — | — |
| HEADACHE | Nervous system disorders | — | — | — |
| URINARY TRACT INFECTION | Infections and infestations | — | — | — |
| BACK PAIN | Musculoskeletal and connective tissue disorders | — | — | — |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | — | — | — |
| FATIGUE | General disorders | — | — | — |
| VOMITING | Gastrointestinal disorders | — | — | — |
| INSOMNIA | Psychiatric disorders | — | — | — |
| SINUSITIS | Infections and infestations | — | — | — |
| ACNE | Skin and subcutaneous tissue disorders | — | — | — |
| ANXIETY | Psychiatric disorders | — | — | — |
| AMENORRHOEA | Reproductive system and breast disorders | — | — | — |
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | — | — | — |
| NASOPHARYNGITIS | Infections and infestations | — | — | — |
| DEPRESSION | Psychiatric disorders | — | — | — |
Most-reported serious reactions: ENDOMETRIOSIS, CONSTIPATION, CHEST PAIN, APPENDICITIS, CLOSTRIDIUM DIFFICILE COLITIS, MENINGITIS VIRAL, PYELONEPHRITIS, UPPER LIMB FRACTURE.
Data from ClinicalTrials.gov NCT01620528 adverse events section.
A randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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