ClinicalTrials.Veeva

Menu

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

AbbVie logo

AbbVie

Status and phase

Completed
Phase 3

Conditions

Uterine Fibroids
Heavy Menstrual Bleeding

Treatments

Drug: Placebo for Elagolix
Drug: Placebo for Estradiol/Norethindrone Acetate
Drug: Elagolix
Drug: Estradiol/Norethindrone Acetate

Study type

Interventional

Funder types

Industry

Identifiers

NCT02654054
M12-815

Details and patient eligibility

About

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.

Enrollment

413 patients

Sex

Female

Ages

18 to 51 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

413 participants in 3 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Placebo for both elagolix twice daily (BID) and norethindrone acetate (E2/NETA) once daily (QD)
Treatment:
Drug: Placebo for Elagolix
Drug: Placebo for Estradiol/Norethindrone Acetate
Elagolix
Experimental group
Description:
Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Treatment:
Drug: Elagolix
Drug: Placebo for Estradiol/Norethindrone Acetate
Elagolix + E2/NETA
Experimental group
Description:
Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Treatment:
Drug: Estradiol/Norethindrone Acetate
Drug: Elagolix

Trial documents
2

Trial contacts and locations

96

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems