Phase 2
Completed N=174
Efficacy and Safety Study of Elagolix Versus Placebo or Leuprorelin Acetate in Endometriosis
Source: ClinicalTrials.gov NCT00797225 ↗Enrolled (actual)
174
Serious AEs
1.2%
Results posted
Sep 2018
Primary outcomePrimary: Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain — -0.35; -0.84; -1.00; -0.94 units on a scale — p=0.0464
Summary
This study is designed to evaluate the safety and beneficial effects of elagolix (NBI-56418) compared to placebo and leuprorelin (an approved endometriosis therapy) over a three month period followed by an additional three months of treatment on elagolix.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain |
-0.35; -0.84; -1.00; -0.94; -0.93; -1.25 | 0.0464 sig |
| SECONDARY Change From Baseline in the Monthly Peak Numerical Rating Score (NRS) for Endometriosis Pain |
-0.20; -1.82; -1.83; -1.48; -0.89; -2.23 | 0.0007 sig |
| SECONDARY Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score |
-0.05; -0.22; -0.21; -0.27; -0.18; -0.34 | 0.0453 sig |
| SECONDARY Change From Baseline in the Monthly Mean Dysmenorrhea Score |
-0.17; -0.64; -0.67; -0.65; -0.40; -0.86 | < 0.0001 sig |
| SECONDARY Change From Baseline in the Monthly Mean Sum of Dysmenorrhea and Non-menstrual Pelvic Pain Scores |
-0.12; -0.43; -0.44; -0.50; -0.24; -0.58 | 0.0011 sig |
| SECONDARY Change From Baseline in the Percentage of Days of Any Analgesic Use |
-5.2; -1.1; -8.4; -8.7; -6.2; -3.4 | — |
| SECONDARY Change From Baseline in the Percentage of Days of Prescription Analgesic Use |
-0.3; 3.4; -1.2; -2.5; -1.3; 1.3 | — |
| SECONDARY Change From Baseline in the Percentage of Days of Narcotic Analgesic Use |
0.0; -0.1; 0.0; -0.1; -0.1; -0.1 | — |
| SECONDARY Change From Baseline in Dyspareunia Component of the Composite Pelvic Signs and Symptoms Score (CPSSS) |
-0.33; -0.46; -0.49; -0.55; -0.72; -0.68 | — |
| SECONDARY Change From Baseline in Dysmenorrhea Component of the CPSSS |
-1.03; -1.29; -1.47; -1.75 | — |
| SECONDARY Change From Baseline in Non-menstrual Pelvic Pain CPSSS Component |
-0.60; -0.58; -0.48; -0.79 | — |
| SECONDARY Patient Global Impression of Change at Weeks 4, 8 and 12 |
3.4; 3.0; 2.9; 3.3; 2.8; 2.5 | — |
| SECONDARY Percentage of Participants With a PGIC Response of Minimally Improved, Much Improved, or Very Much Improved |
56.1; 74.4; 65.1; 50.0; 75.6; 81.4 | — |
| SECONDARY Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved |
7.3; 25.6; 32.6; 27.3; 36.6; 53.5 | — |
| SECONDARY Change From Baseline in Endometriosis Health Profile-5 (EHP-5) at Week 12 |
-14.0; -19.0; -25.0; -31.8; -18.3; -17.9 | — |
| SECONDARY Concentration of Serum Estradiol |
39.10; 43.40; 47.50; 46.20; 49.50; 36.40 | — |
| SECONDARY Percent Change From Baseline in Bone Mineral Density of the Femur at Week 12 |
-0.90; -0.342; -0.5623; -1.122 | — |
| SECONDARY Percent Change From Baseline in Bone Mineral Density of the Spine at Week 12 |
0.106; -1.053; -0.799; -1.633 | — |
| SECONDARY Percent Change From Baseline in Bone Mineral Density of the Femur at Week 24 |
-0.549; -0.699; -0.126; -0.573; -1.784; -1.783 | — |
| SECONDARY Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24 |
-1.288; -1.855; -0.990; -0.648; -2.899; -4.378 | — |
| SECONDARY Change From Baseline in Serum N-telopeptide Concentration at Week 12 |
0.62; 0.77; 2.04; 3.18 | — |
| SECONDARY Average Number of Hot Flashes Per Day |
0.00; 0.00; 0.00; 0.00; 0.11; 0.22 | — |
| SECONDARY Percentage of Days With Uterine Bleeding |
21.10; 18.32; 22.32; 21.05; 21.46; 10.78 | — |
| SECONDARY Number of Days to First Posttreatment Menses |
22.5; 26.0; 26.0; 27.0; 29.0; 28.0 | — |
Eligibility Criteria
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 (23-33 day)
- Agree to use two forms of non-hormonal contraception during the study
Exclusion Criteria
- Received a Gonadotropin-releasing hormone (GnRH) agonist, GnRH antagonist, danazol, or have received any of these agents within 6 months of the start of screening.
- Received subcutaneous medroxyprogesterone acetate (DMPA-SC) or intramuscular (i.m.) medroxyprogesterone acetate (DMPA-IM), or have received either 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
- Are using systemic steroids on a chronic or regular basis within 3 months
- Have uterine fibroids or other pelvic lesions ≥ 3 cm in diameter
- Have had a hysterectomy or oophorectomy
- Have pelvic pain that is not caused by endometriosis
- Have unstable medical condition or chronic disease
- Have been pregnant within the last 6 months and is currently breast feeding
Data sourced from ClinicalTrials.gov (NCT00797225). 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. Informational only — not medical advice.