Phase 2 N=137 Randomized Quadruple-blind Treatment

Efficacy and Safety Study of Elagolix in Women With Endometriosis

Endometriosis, Pain

Bottom Line

View on ClinicalTrials.gov: NCT00973973 ↗

Enrolled (actual)

137

Serious AEs

2.0%

Results posted

Sep 2018

Primary outcome: Primary: Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Double-blind Treatment Phase — -0.24; -0.49; -0.37; -1.13 units on a scale — p=0.0262

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Placebo (Drug); Elagolix (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: AbbVie
Primary completion: Sep 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Double-blind Treatment Phase	-0.24; -0.49; -0.37; -1.13	0.0262 sig
PRIMARY Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Open-label and Posttreatment Phases	-0.768; -1.060; -1.325; -1.022; -1.026; -0.991	—
PRIMARY Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score During the Double-Blind Treatment Phase	-0.05; -0.26; -0.19; -0.47	0.0163 sig
PRIMARY Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score During the Open-label and Posttreatment Phases	-0.355; -0.727; -0.422; -0.763; -0.524; -0.759	—
PRIMARY Change From Baseline in the Monthly Mean Cumulative Pain Score During the Double-Blind Treatment Phase	-0.11; -0.32; -0.21; -0.55	0.0089 sig
PRIMARY Change From Baseline in the Monthly Mean Cumulative Pain Score During the Open-label and Posttreatment Phases	-0.433; -0.781; -0.530; -0.793; -0.615; -0.798	—
PRIMARY Change From Baseline in the Monthly Mean Dyspareunia Score During the Double-Blind Treatment Phase	-0.07; -0.34; -0.23; -0.61	0.0360 sig
PRIMARY Change From Baseline in the Monthly Mean Dyspareunia Score During the Open-label and Posttreatment Phases	-0.334; -0.696; -0.453; -0.738; -0.492; -0.778	—
SECONDARY Percentage of Participants With a Response in Monthly Mean Dysmenorrhea Score at Week 8	56.3; 68.8; 43.8; 68.8; 32.8; 62.5	—
SECONDARY Percentage of Participants With a Response in Monthly Mean Non-menstrual Pelvic Pain Score at Week 8	51.6; 79.7; 40.6; 68.8; 32.8; 62.5	—
SECONDARY Percentage of Participants With a Response in Monthly Mean Cumulative Pain Score at Week 8	51.6; 76.6; 40.6; 70.3; 37.5; 59.4	—
SECONDARY Percentage of Participants With a Response in Monthly Mean Dyspareunia Score at Week 8	44.7; 73.3; 38.3; 64.4; 34.0; 57.8	—
SECONDARY Change From Baseline in the Percentage of Days of Any Analgesic Use During the Double-Blind Treatment Phase	-5.78; -15.62; -9.19; -21.63	0.0137 sig
SECONDARY Change From Baseline in the Percentage of Days of Any Analgesic Use During the Open-Label and Posttreatment Phases	-14.91; -27.70; -18.34; -26.27; -19.82; -26.35	—
SECONDARY Change From Baseline in the Percentage of Days of Prescription Analgesic Use During the Double-Blind Treatment Phase	0.92; -5.29; -0.82; -7.16	0.0244 sig
SECONDARY Change From Baseline in the Percentage of Days of Prescription Analgesic Use During the Open-Label and Posttreatment Phases	-2.34; -8.53; -5.52; -7.52; -5.21; -6.06	—
SECONDARY Change From Baseline in the Percentage of Days of Narcotic Analgesic Use During the Double-Blind Treatment Phase	-0.51; -3.63; -1.19; -4.71	0.0893
SECONDARY Change From Baseline in the Percentage of Days of Narcotic Analgesic Use During the Open-Label and Posttreatment Phases	-1.91; -4.79; -4.03; -3.64; -2.79; -5.41	—
SECONDARY Change From Baseline to the End of the Double-blind Treatment Phase in Composite Pelvic Signs and Symptoms Score (CPSSS) Total Score and Component Scores	-2.19; -4.45; -0.39; -1.44; -0.54; -0.90	< 0.0001 sig
SECONDARY Change From Baseline to the End of the Open-label Treatment Phase in Composite Pelvic Signs and Symptoms Score (CPSSS) Total Score and Component Scores	-5.571; -5.404; -1.544; -1.386; -1.000; -1.211	—
SECONDARY Patient Global Impression of Change During the Double-blind Treatment Phase	3.6; 2.8; 3.4; 2.4	0.0012 sig
SECONDARY Patient Global Impression of Change During the Open-Label and Posttreatment Phases	2.5; 2.0; 2.4; 1.8; 2.2; 2.0	—
SECONDARY Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved During the Double-blind Treatment Phase	18.5; 37.9; 30.2; 60.3	0.0136 sig
SECONDARY Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved During the Open-label Treatment Phase	59.0; 76.3; 61.7; 76.3; 71.9; 71.9	—
SECONDARY Change From Baseline to the End of the Double-blind Treatment Phase in Endometriosis Health Profile-5 (EHP-5)	-12.3; -29.0; -12.7; -35.3; -10.3; -17.1	—
SECONDARY Change From Baseline to the End of the Open-label Treatment Phase in Endometriosis Health Profile-5 (EHP-5)	-30.3; -36.4; -35.1; -39.5; -22.8; -23.7	—
SECONDARY Percentage of Days With Uterine Bleeding During the Double- Blind Treatment Phase	24.29; 22.98; 23.91; 14.00	—
SECONDARY Number of Days to First Posttreatment Menses	22.0; 25.0	—

Summary

The purpose of this study is to evaluate elagolix (NBI-56418) compared to placebo for its effects on endometriosis related pelvic pain and its safety.

Eligibility Criteria

Inclusion Criteria

Be female, aged 18 to 49 years, inclusive.
Have moderate to severe pelvic pain due to endometriosis.
Have a history of regular menstrual cycles.
Have been surgically (laparoscopy or laparotomy) diagnosed with endometriosis within 8 years of the start of screening.
Have a Body Mass Index (BMI) of 18 to 36 kg/m², inclusive.
Agree to use two forms of non-hormonal contraception during the study.

Exclusion Criteria

Are currently receiving gonadotropin-releasing hormone (GnRH) agonist, a GnRH antagonist other than NBI-56418, or danazol or have received any of these agents within 6 months of the start of screening.
Are currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or intramuscular medroxyprogesterone acetate (DMPA-IM) or have received any of these agents within 3 months of the start of screening.
Are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within the last month.
Have had surgery for endometriosis within the last month.
Have had a hysterectomy or bilateral oophorectomy.
Are using systemic steroids on a chronic or regular basis within 3 months.
Have uterine fibroids ≥ 3 cm in diameter.
Have pelvic pain that is not caused by endometriosis.
Have unstable medical condition or chronic disease.
Have been pregnant within the last six months.
Currently breast feeding.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00973973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.