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Long-Term Safety and Efficacy of Elagolix in Combination With Estradiol/ Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

Female
Age
18 - 50
Phase 3

Brief Summary

A Phase 3b Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women



ClinicalTrials.gov Identifier: NCT03271489
Recruitment Status: Active, not recruiting
First Posted: 9/5/2017 12:00:00 AM
Last Update Posted: 7/17/2019 12:00:00 AM

Keywords

Hemorrhage
Leiomyoma
Menorrhagia
Myofibroma

Intervention/Treatment

Other: Elagolix Placebo / Tablets

You may be eligible to join if...




- 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) and 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 in 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.

You may NOT be eligible to join if...



- 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
during the course of the study. over the counter and prescription topical, inhaled,
intranasal or intra-articular injectable (for occasional use) corticosteroids are
allowed.

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