Status:
COMPLETED
Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
Lead Sponsor:
AbbVie
Conditions:
Heavy Uterine Bleeding
Uterine Fibroids
Eligibility:
FEMALE
18-51 years
Phase:
PHASE2
Brief Summary
This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bl...
Eligibility Criteria
Inclusion
- Subject is pre-menopausal female 18 to 51 years of age at Screening.
- Subject has diagnosis of uterine fibroids documented by a Pelvic Ultrasound.
- Subject has heavy uterine bleeding associated with uterine fibroids.
Exclusion
- Subject has had a myomectomy, uterine artery embolization or high intensity focused ultrasound for fibroid destruction within 6 months prior to Screening or endometrial ablation within 5 years prior to Screening.
- Subject has a history of osteoporosis or other metabolic bone disease.
- Subject shows evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including depression, schizophrenia, bipolar disorder), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes. Subject has any history of attempted suicide.
- Subject has a history of clinically significant condition(s) including but not limited to: \* Symptomatic Endometriosis \* Epilepsy or seizures \* Type 1 diabetes \* Chronic kidney disease \* Any cancer (except treated basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy
Key Trial Info
Start Date :
April 8 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
571 Patients enrolled
Trial Details
Trial ID
NCT01817530
Start Date
April 8 2013
End Date
December 1 2015
Last Update
July 21 2020
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