Phase 3
Completed N=433
An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Uterine Fibroids · Heavy Menstrual Bleeding
Source: ClinicalTrials.gov NCT02925494 ↗
Enrolled (actual)
433
Serious AEs
2.8%
Results posted
Jun 2020
Primary outcomePrimary: Percentage of Participants Meeting the Criteria for Responder — 85.7; 66.7; 89.4; 87.9 percentage of participants
◆ Published Evidence
Established
67citations · ~11 / year
Elagolix Treatment for Up to 12 Months in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas.
Summary
This is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate the long-term efficacy and safety of elagolix administered alone and in combination with estradiol/norethindrone acetate for an additional six months in the treatment of heavy menstrual bleeding associated with uterine fibroids.
Linked Publications (2)
-
Elagolix Treatment for Up to 12 Months in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas.
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Population Pharmacokinetics of Elagolix in Combination with Low-Dose Estradiol/Norethindrone Acetate in Women with Uterine Fibroids.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Meeting the Criteria for Responder |
85.7; 66.7; 89.4; 87.9 | — |
| SECONDARY Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period |
-151.7; -61.7; -253.4; -186.5; -210.9; -203.1 | — |
| SECONDARY Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period |
-46.5; -28.2; -94.0; -87.7; -87.2; -79.4 | — |
| SECONDARY Percentage of Participants With Suppression of Bleeding at the Final Month |
88.7; 56.0; 89.2; 74.8 | — |
| SECONDARY Percentage of Participants With Baseline Hemoglobin Concentration ≤ 10.5 g/dL and an Increase From Baseline > 2 g/dL at Month 6 During the Treatment Period |
70.6; 36.4; 71.4; 72.5 | — |
Eligibility Criteria
Inclusion Criteria
- Participant has completed the 6-Month Treatment Period of their respective Pivotal Study (either Study M12-815 or Study M12-817).
- Participant did not meet removal criteria in bone mineral density (BMD) decrease in the spine, total hip and femoral neck at Month 6 of the Treatment Period of their respective Pivotal Study
- Participant has negative urine and/or serum pregnancy test(s) results were consistently negative during the Treatment Period of their respective Pivotal Study and prior to first dose in this study.
- Participant's endometrial biopsy from the Month 6 Visit of their respective Pivotal Study shows no clinically significant endometrial pathology.
Exclusion Criteria
- Participant met criteria for removal from therapy in her respective Pivotal Study.
- Participant is planning a pregnancy within the next 18 months.
- Participant has current suicidal markers as noted at the Month 6 visit of her respective pivotal study.
- Participant has any new medical conditions that may be unsuitable for participation.
- Participant is using any systemic corticosteroids for over 14 days or is likely to require treatment with systemic corticosteroids during the course of the study. Over-the-counter and prescription topical, inhaled, intranasal or injectable (for occasional use) corticosteroids are allowed.
Data sourced from ClinicalTrials.gov (NCT02925494) and the linked publication. 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.