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Alabama Clinical Therapeutics | Birmingham, AL

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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

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AbbVie

Status and phase

Active, not recruiting
Phase 3

Conditions

Uterine Fibroids
Heavy Menstrual Bleeding

Treatments

Other: E2/NETA Placebo
Drug: E2/NETA
Drug: Elagolix
Other: Elagolix Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03271489
M16-283

Details and patient eligibility

About

This is 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 is double-blinded in the first year and an open-label for the next three years.

Enrollment

500 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

500 participants in 2 patient groups, including a placebo group

Elagolix plus estradiol (E2)/norethindrone acetate (NETA)
Experimental group
Description:
Elagolix plus estradiol (E2)/norethindrone acetate (NETA)
Treatment:
Drug: Elagolix
Drug: E2/NETA
Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Other: Elagolix Placebo
Other: E2/NETA Placebo

Trial contacts and locations

156

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Data sourced from clinicaltrials.gov

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