Long-Term Safety and Efficacy of Elagolix in Combination With Estradiol/ Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Status: | Recruiting |
---|---|
Conditions: | Cervical Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 3/21/2019 |
Start Date: | September 13, 2017 |
End Date: | May 16, 2022 |
Contact: | ABBVIE CALL CENTER |
Email: | abbvieclinicaltrials@abbvie.com |
Phone: | 847.283.8955 |
A Phase 3b Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
This phase 3b study seeks to evaluate the safety and efficacy 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 in the second year.
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 in the second year.
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 in 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.
We found this trial at
156
sites
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2441 Ridgecrest Drive Southeast
Albuquerque, New Mexico 87102
Albuquerque, New Mexico 87102
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
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7043 Highway 190 East Service Road
Covington, Louisiana 70433
Covington, Louisiana 70433
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5323 Harry Hines Boulevard
Dallas, Texas 75390
Dallas, Texas 75390
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500 University Drive
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
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