Phase 3
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
Bottom Line
View on ClinicalTrials.gov: NCT02925494 ↗Enrolled (actual)
433
Serious AEs
2.8%
Results posted
Jun 2020
Primary outcome: Primary: Percentage of Participants Meeting the Criteria for Responder — 85.7; 66.7; 89.4; 87.9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Estradiol/Norethindrone Acetate (Drug); Elagolix (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- AbbVie
- Primary completion
- May 2018
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 | — |
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.
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). 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.