Phase 3
Completed N=413
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
Uterine Fibroids · Heavy Menstrual Bleeding
Source: ClinicalTrials.gov NCT02654054 ↗
Enrolled (actual)
413
Serious AEs
2.7%
Results posted
Jun 2020
Primary outcomePrimary: Percentage of Participants Meeting the Criteria for Responder — 8.7; 84.1; 68.5 percentage of participants — p=< 0.001
◆ Published Evidence
Established
21citations · ~4 / year
Efficacy and safety of elagolix with add-back therapy in women with uterine fibroids and coexisting adenomyosis.
Summary
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.
Linked Publications (5)
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Efficacy and safety of elagolix with add-back therapy in women with uterine fibroids and coexisting adenomyosis.
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Population Pharmacokinetics of Elagolix in Combination with Low-Dose Estradiol/Norethindrone Acetate in Women with Uterine Fibroids.
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Integrating real-world data and modeling to project changes in femoral neck bone mineral density and fracture risk in premenopausal women.
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Reduction of Heavy Menstrual Bleeding in Women Not Designated as Responders to Elagolix Plus Add Back Therapy for Uterine Fibroids.
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Impact of demographic and clinical factors on elagolix plus add-back therapy effects on patient-reported nonbleeding symptoms in women with heavy menstrual bleeding and uterine fibroids: a post hoc analysis of data from two clinical trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Meeting the Criteria for Responder |
8.7; 84.1; 68.5 | < 0.001 sig |
| SECONDARY Change From Baseline in MBL Volume to the Final Month |
0.8; -221.5; -176.7 | < 0.001 sig |
| SECONDARY Percentage of Participants With Suppression of Bleeding at the Final Month |
4.4; 84.0; 56.8 | < 0.001 sig |
| SECONDARY Change From Baseline in MBL Volume to Month 6 |
-2.3; -236.2; -194.7 | < 0.001 sig |
| SECONDARY Change From Baseline in MBL Volume to Month 3 |
6.1; -234.7; -192.2 | < 0.001 sig |
| SECONDARY Percentage of Participants With Baseline Hemoglobin <= 10.5 g/dL Who Have an Increase in Hemoglobin > 2 g/dL at Month 6 |
16.1; 65.9; 61.5 | < 0.001 sig |
| SECONDARY Change From Baseline in MBL Volume to Month 1 |
-19.0; -209.0; -135.2 | < 0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Subject is a premenopausal female at the time of Screening.
- Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound (transabdominal ultrasound/transvaginal ultrasound).
- Subject has heavy menstrual bleeding associated with uterine fibroids as evidenced by menstrual blood loss > 80 mL during each of two screening menses as measured by the alkaline hematin method.
- Subject has negative urine and/or serum pregnancy test in Screening and just prior to first dose.
- Subject has an adequate endometrial biopsy performed during Screening, the results of which show no clinically significant endometrial pathology.
Exclusion Criteria
- Subject has screening pelvic ultrasound or saline infusion sonohysterography results that show a clinically significant gynecological disorder.
- Subject has history of osteoporosis or other metabolic bone disease.
- Subject has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis.
- Subject has a history of major depression or post-traumatic stress disorder (PTSD) within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder).
- Subject is using any systemic corticosteroids for over 14 days within 3 months prior to Screening 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 (NCT02654054) 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.