Phase 2
N=567
Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
Heavy Uterine Bleeding · Uterine Fibroids
Bottom Line
View on ClinicalTrials.gov: NCT01817530 ↗Enrolled (actual)
567
Serious AEs
4.6%
Results posted
Jul 2020
Primary outcome: Primary: Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month — 26.56; 91.94; 85.25; 79.03 percentage of participants — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Elagolix placebo (Other); Elagolix (Drug); 0.5 mg estradiol / 0.1 mg norethindrone acetate (Drug); 1 mg estradiol / 0.5 mg norethindrone acetate (Drug); E2/NETA placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- AbbVie
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month |
26.56; 91.94; 85.25; 79.03; 31.58; 90.14 | < 0.001 sig |
| SECONDARY Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 56 to 29 Days of Treatment |
11.29; 94.83; 88.14; 85.00; 18.42; 85.29 | < 0.001 sig |
| SECONDARY Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 84 to 57 Days of Treatment |
19.67; 96.43; 89.47; 79.31; 21.62; 86.36 | < 0.001 sig |
| SECONDARY Percentage of Participants Who Achieved an MBL Volume of < 80 mL at the Final Month |
32.81; 91.94; 88.52; 79.03; 36.84; 91.55 | < 0.001 sig |
| SECONDARY Percentage of Participants With a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month |
31.25; 93.55; 86.89; 82.26; 35.53; 90.14 | < 0.001 sig |
| SECONDARY Percentage of Participants Who Achieved Amenorrhea During the Last 56 Days of Treatment |
1.6; 56.1; 33.3; 28.3; 1.3; 50.7 | < 0.001 sig |
| SECONDARY Percentage of Participants Who Achieved Suppression of Bleeding During the Last 56 Days of Treatment |
1.6; 75.4; 52.6; 43.3; 2.7; 67.2 | < 0.001 sig |
| SECONDARY Mean Change in the Number of Bleeding Days From Baseline to Month 6 |
-1.2; -4.9; -2.7; -1.1; -1.4; -3.3 | 0.007 sig |
| SECONDARY Mean Change in the Number of Heavy Bleeding Days From Baseline to Month 6 |
-1.0; -2.0; -1.9; -1.7; -0.7; -1.2 | 0.001 sig |
| SECONDARY Change in Bleeding Severity Scores From Baseline at the Final Month |
-0.3; -0.7; -0.4; -0.1; -0.2; -0.4 | 0.004 sig |
| SECONDARY Mean Change in Hemoglobin Concentration From Baseline to Final Visit |
0.6; 1.9; 1.9; 1.4; 0.3; 1.4 | < 0.001 sig |
| SECONDARY Mean Percentage Change From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit |
1.7; -41.9; -24.6; -9.8; 5.4; -34.4 | < 0.001 sig |
| SECONDARY Mean Percentage Change From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit |
6.9; -35.5; -20.3; -3.7; 6.7; -33.6 | < 0.001 sig |
| SECONDARY Mean Percentage Change From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit |
7.3; -30.9; -19.4; -7.3; 8.4; -24.7 | < 0.001 sig |
| SECONDARY Percentage of Participants With ≥ 25% Reduction From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit |
13.2; 79.6; 50.0; 31.9; 9.4; 66.7 | < 0.001 sig |
| SECONDARY Percentage of Participants With ≥ 25% Reduction From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit |
13.2; 67.3; 46.2; 23.4; 10.9; 63.2 | < 0.001 sig |
| SECONDARY Percentage of Participants With ≥ 25% Reduction From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit |
5.2; 73.1; 42.9; 18.5; 1.4; 57.1 | < 0.001 sig |
| SECONDARY Change From Baseline to Each Month in Non-Bleeding Uterine Fibroids Symptom (NBUFSQ) Questionnaire |
-3.3; -3.4; -3.1; -1.4; 0.4; -2.7 | 0.556 |
| SECONDARY Percentage of Participants Who Successfully Avoided Surgical or Invasive Procedures for Uterine Fibroids |
— | — |
Summary
This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids.
Eligibility Criteria
Inclusion Criteria
- Subject is pre-menopausal female 18 to 51 years of age at Screening.
- Subject has diagnosis of uterine fibroids documented by a Pelvic Ultrasound.
- Subject has heavy uterine bleeding associated with uterine fibroids.
Exclusion Criteria
- Subject has had a myomectomy, uterine artery embolization or high intensity focused ultrasound for fibroid destruction within 6 months prior to Screening or endometrial ablation within 5 years prior to Screening.
- Subject has a history of osteoporosis or other metabolic bone disease.
- Subject shows evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including depression, schizophrenia, bipolar disorder), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes. Subject has any history of attempted suicide.
- Subject has a history of clinically significant condition(s) including but not limited to: * Symptomatic Endometriosis * Epilepsy or seizures * Type 1 diabetes * Chronic kidney disease * Any cancer (except treated basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy
Data sourced from ClinicalTrials.gov (NCT01817530). 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.