Phase 2 N=155 Randomized Quadruple-blind Treatment

An Efficacy and Safety Study of Elagolix (NBI-56418) in Women With Endometriosis

Endometriosis, Pain

Bottom Line

View on ClinicalTrials.gov: NCT00619866 ↗

Enrolled (actual)

155

Serious AEs

0.5%

Results posted

Sep 2018

Primary outcome: Primary: Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain at Week 12 — -0.88; -1.19; -1.25 units on a scale — p=0.2311

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Elagolix (Drug); placebo (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: AbbVie
Primary completion: Apr 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain at Week 12	-0.88; -1.19; -1.25	0.2311
SECONDARY Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain	-0.60; -0.90; -0.83; -0.71; -1.23; -0.94	0.2041
SECONDARY Change From Baseline in the Monthly Peak Numerical Rating Score (NRS) for Endometriosis Pain	-1.27; -1.39; -1.58; -1.25; -1.94; -2.41	0.7990
SECONDARY Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score	-0.14; -0.18; -0.16; -0.12; -0.30; -0.17	0.5744
SECONDARY Change From Baseline in the Monthly Mean Dysmenorrhea Score	-0.20; -0.49; -0.40; -0.29; -0.71; -0.79	0.0286 sig
SECONDARY Change From Baseline in the Monthly Mean Total of Dysmenorrhea and Non-menstrual Pelvic Pain Scores	-0.18; -0.34; -0.29; -0.18; -0.48; -0.33	0.0603
SECONDARY Percentage of Days With No Pain Based on NRS	27.600; 25.380; 25.515; 35.252; 36.401; 32.355	—
SECONDARY Percentage of Days With No Pain Based Based on Non-menstrual Pelvic Pain Daily Assessment	34.939; 36.821; 38.530; 42.986; 45.469; 44.443	—
SECONDARY Percentage of Days With No Pain Based Based on Dysmenorrhea Daily Assessment	26.350; 14.340; 21.086; 30.513; 43.411; 39.475	—
SECONDARY Percentage of Days With No Pain Based Based on Total Score of Non-menstrual Pelvic Pain and Dysmenorrhea Daily Assessment	33.009; 32.940; 35.967; 39.586; 44.020; 43.230	—
SECONDARY Change From Baseline in the Percentage of Days of Any Analgesic Use	-4.8; -8.7; -6.8; -5.8; -12.6; -10.4	—
SECONDARY Change From Baseline in the Percentage of Days of Prescription Analgesic Use	-1.0; -4.0; -2.3; -0.8; -3.2; -3.2	—
SECONDARY Change From Baseline in the Percentage of Days of Narcotic Analgesic Use	-0.8; -2.5; -2.1; -0.8; -1.8; -3.0	—
SECONDARY Percentage of Participants With 30% Decrease From Baseline in Monthly Mean NRS	38.5; 43.1; 47.1; 54.5; 60.4; 51.1	—
SECONDARY Percentage of Participants With 30% Decrease From Baseline in Monthly Peak NRS	30.8; 35.3; 31.4; 38.6; 43.8; 48.9	—
SECONDARY Percentage of Participants With 50% Decrease From Baseline in Monthly Mean NRS	21.2; 37.3; 25.5; 36.4; 45.8; 38.3	—
SECONDARY Percentage of Participants With 50% Decrease From Baseline in Monthly Peak NRS	11.5; 17.6; 19.6; 11.4; 25.0; 36.2	—
SECONDARY Change From Baseline in Dyspareunia Component of the Composite Pelvic Signs and Symptoms Score (CPSSS)	-0.19; -0.21; -0.56; -0.15; -0.68; -0.66	—
SECONDARY Patient Global Impression of Change at Weeks 4, 8 and 12	3.4; 3.0; 2.8; 3.0; 2.3; 2.4	—
SECONDARY Percentage of Participants With a PGIC Response of Minimally Improved, Much Improved, or Very Much Improved	54.2; 62.0; 80.0; 67.4; 91.7; 84.4	—
SECONDARY Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved	12.5; 34.0; 38.0; 37.0; 58.3; 60.0	—
SECONDARY Change From Baseline in Endometriosis Health Profile-5 (EHP-5) at Week 12	-11.8; -25.0; -17.3; -10.5; -25.6; -22.6	—
SECONDARY Percent Change From Baseline in Bone Mineral Density of the Femur at Week 12	-0.283; -0.294; -0.382	—
SECONDARY Percent Change From Baseline in Bone Mineral Density of the Femur at Week 24	-0.743; -1.024; -0.924; -0.076	—
SECONDARY Percent Change From Baseline in Bone Mineral Density of the Spine at Week 12	0.375; -0.045; -0.937	—
SECONDARY Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24	-1.032; -1.631; -0.692; 0.681	—

Summary

This study is designed to see how elagolix works compared to placebo in women with endometriosis and to see the effect, if any, on bone mineral density.

Eligibility Criteria

Inclusion Criteria

Be female, aged 18 to 49 years, inclusive
Have moderate to severe pelvic pain due to endometriosis
Have been surgically (laparoscopy) diagnosed with endometriosis within the last 8 years and have recurrent or persistent endometriosis symptoms
Have regular menstrual cycle
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 or GnRH antagonist 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 (NCT00619866). 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.