Status:
COMPLETED
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
Lead Sponsor:
AbbVie
Conditions:
Heavy Menstrual Bleeding
Uterine Fibroids
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
Brief 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 u...
Detailed Description
478 participants were randomly assigned at a ratio of 2:1 to the following treatment groups: 1. Elagolix 300 mg twice daily (BID) plus estradiol 1.0 mg/norethindrone acetate 0.5 mg (E2/NETA) once dai...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2024
Estimated Enrollment :
478 Patients enrolled
Trial Details
Trial ID
NCT03271489
Start Date
September 13 2017
End Date
June 28 2024
Last Update
July 22 2025
Active Locations (157)
Enter a location and click search to find clinical trials sorted by distance.
1
Alabama Clinical Therapeutics /ID# 160835
Birmingham, Alabama, United States, 35235-3430
2
Alabama Clinical Therapeutics /ID# 160927
Birmingham, Alabama, United States, 35235-3430
3
Choice Research, LLC /ID# 161498
Dothan, Alabama, United States, 36303
4
Southern Women's Specialists PC /ID# 161531
Fairhope, Alabama, United States, 36532-3029