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
- Conditions
- Uterine FibroidsHeavy Menstrual Bleeding
- Interventions
- Registration Number
- NCT03271489
- Lead Sponsor
- AbbVie
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 478
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Elagolix Placebo Placebo Elagolix plus estradiol (E2)/norethindrone acetate (NETA) Elagolix Elagolix plus estradiol (E2)/norethindrone acetate (NETA) Placebo E2/NETA Placebo Placebo Elagolix plus estradiol (E2)/norethindrone acetate (NETA) E2/NETA Elagolix plus estradiol (E2)/norethindrone acetate (NETA)
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events (AEs) Month 60 An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
- Secondary Outcome Measures
Name Time Method Change in Bone Mineral Density (BMD) From Baseline through Month 60 Bone mineral density (BMD) is measured by dual X-ray absorptiometry (DXA).
Trial Locations
- Locations (157)
Alabama Clinical Therapeutics /ID# 160835
🇺🇸Birmingham, Alabama, United States
Alabama Clinical Therapeutics /ID# 160927
🇺🇸Birmingham, Alabama, United States
Choice Research, LLC /ID# 161498
🇺🇸Dothan, Alabama, United States
Southern Women's Specialists PC /ID# 161531
🇺🇸Fairhope, Alabama, United States
E Squared Research /ID# 163645
🇺🇸Huntsville, Alabama, United States
Women's Health Alliance of Mobile /ID# 161443
🇺🇸Mobile, Alabama, United States
Mobile, OBGYN P.C. /ID# 161530
🇺🇸Mobile, Alabama, United States
Mesa Obstetricians and Gynecologists /ID# 160955
🇺🇸Mesa, Arizona, United States
Noble Clinical Research /ID# 166949
🇺🇸Tucson, Arizona, United States
Vision's Clinical Research-Tucson /ID# 161508
🇺🇸Tucson, Arizona, United States
Scroll for more (147 remaining)Alabama Clinical Therapeutics /ID# 160835🇺🇸Birmingham, Alabama, United States