Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Ma… (NCT03271489) | Clinical Trial Compass
CompletedPhase 3
Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
United States478 participantsStarted 2017-09-13
Plain-language summary
This randomized multicenter phase 3b study seeks to evaluate the safety of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. This study was double-blind (DB) during the first 12 months and open-label (OL) for the next 36 months.
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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Inclusion Criteria:
* Participant is a premenopausal female at the time of Screening.
* Participant has a diagnosis of uterine fibroids documented by a Pelvic Ultrasound \[Transabdominal ultrasound (TAU) or transvaginal ultrasound (TVU)\].
* Participant has Heavy Menstrual Bleeding (HMB) associated with uterine fibroids as evidenced by Menstrual Blood Loss (MBL) \> 80 mL during each of two screening menses as measured by the alkaline hematin method.
* Participant has negative urine and/or serum pregnancy test during Washout (if applicable) and/or Screening and just prior to first dose.
* Participant has an adequate endometrial biopsy performed during Screening, the results of which show no clinical significant endometrial pathology.
Exclusion Criteria:
* Participant has screening pelvic ultrasound or Saline Infusion Sonohysterography (SIS) results that show a clinically significant gynecological disorder.
* Participant has history of osteoporosis or other metabolic bone disease.
* Participant has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis.
* Participant has a history of major depression or post-traumatic stress disorder (PTSD) episode within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder).
* Participant is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids du…