Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)
CompletedPhase 3Results postedLast updated 13 July 2021
What this trial tests
Phase 3 trial testing Elagolix in Uterine Fibroids in 378 participants. Completed in 23 January 2019.
Adults 18 to 51, female only, with Uterine Fibroids or Heavy Menstrual Bleeding. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Meeting the Criteria for ResponderPrimary· Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
Percentage of responders, defined as participants who met the following conditions:
* Menstrual blood loss (MBL) volume \< 80 mL during the Final Month (the last 28 days prior to and including the Reference Day, which is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date), and
* ≥ 50% reduction in MBL volume from Baseline to the Final Month.
Participants who prematurely discontinued study drug due to "lack of efficacy
Group
Value
95% CI
Placebo
10.5
Elagolix
76.9
Elagolix + E2/NETA
76.5
Change From Baseline in MBL Volume to the Final MonthSecondary· Baseline and Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.
The Reference Day is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date.
Group
Value
95% CI
Placebo
-4.3
± 15.44
Elagolix
-198.8
± 15.44
Elagolix + E2/NETA
-168.8
± 10.72
Percentage of Participants With Suppression of Bleeding at the Final MonthSecondary· Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
Suppression of bleeding is defined as having 0 days of bleeding (spotting is allowed) during the Final Month with the interval starting from Study Day 11.
The Reference Day is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date.
Group
Value
95% CI
Placebo
4.7
Elagolix
88.9
Elagolix + E2/NETA
61.0
Change From Baseline in MBL Volume to Month 6Secondary· Month 0 (Baseline), Month 6
Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.
Group
Value
95% CI
Placebo
28.5
± 16.68
Elagolix
-223.7
± 17.98
Elagolix + E2/NETA
-198.1
± 11.89
Change From Baseline in MBL Volume to Month 3Secondary· Month 0 (Baseline), Month 3
Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.
Group
Value
95% CI
Placebo
-14.2
± 11.57
Elagolix
-211.1
± 11.96
Elagolix + E2/NETA
-200.3
± 8.17
Percentage of Participants With Baseline Hemoglobin <= 10.5 g/dL Who Have an Increase in Hemoglobin > 2 g/dL at Month 6Secondary· Month 0 (Baseline), Month 6
Group
Value
95% CI
Placebo
20.8
Elagolix
40.0
Elagolix + E2/NETA
50.0
Change From Baseline in MBL Volume to Month 1Secondary· Month 0 (Baseline), Month 1
Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.
Group
Value
95% CI
Placebo
-2.1
± 14.31
Elagolix
-196.6
± 14.74
Elagolix + E2/NETA
-127.0
± 10.14
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 160.3 (51.75), 155.2 (65.19), and 158.7 (54.68) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07532876 — Comparison of Elagolix and OCPs in Reducing Endometriosis Associated Pelvic Pain
· Phase 4
· enrolling by invitation
NCT06076486 — A Clinical Trial to Evaluate Efficacy and Safety of Elagolix Tablets in Women With Moderate or Severe Endometriosis-asso
· Phase 3
· completed
NCT03746535 — Cardiovascular Disease Risk in Women With Endometriosis
· EARLY_PHASE1
· recruiting
NCT05038878 — An Oral GnRH Antagonist to Treat Mild Autonomous Cortisol Excess (MACE) Due to Adrenal Adenomas in Postmenopausal Women
· Phase 4
· terminated
Other recruiting trials for Uterine Fibroids
Currently open trials in the same condition.
NCT07378098 — to Evaluate the Efficacy and Safety of KLH-2109 in Patients With Uterine Fibroids and Menorrhagia
· Phase 3
· recruiting
NCT07486622 — Transvaginal Electromechanical Fragmentation and Removal of Large Uterus in a Sealed Bag: The First Group of Clinical St
· active not recruiting
NCT06671548 — Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
· Phase 3
· recruiting
NCT05448365 — Vitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in Uterine Fibroid
· NA
· recruiting
NCT04126824 — Effect of Addition of Steroids on Duration of Analgesia
· EARLY_PHASE1
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 13 July 2021
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