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 (Replicate Study)

  • Interventional
  • Not Recruiting
  • NCT02691494
Eligibility Details Visit Clinicaltrials.gov

A Phase 3 Study to Evaluate the 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

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.

Gender
Female

Age Group
18 Years to 51 Years

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Subject is a premenopausal female at the time of Screening.

         - Subject has a diagnosis of uterine fibroids documented by a Pelvic Ultrasound (TAU, TVU).

         - Subject has HMB associated with uterine fibroids as evidenced by MBL > 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 SIS 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.

At a Glance

National Government IDNCT02691494

IRB#IRB16-0991

Lead SponsorAbbVie

Lead PhysicianMonica Christmas

Collaborator(s)N/A

EligibilityFemale
18 Years to 51 Years
Not Recruiting