Status:
COMPLETED
Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Heavy Uterine Bleeding
Uterine Fibroids
Eligibility:
FEMALE
20-49 years
Phase:
PHASE2
Brief Summary
The purpose of this proof-of-concept study is to assess the safety and effectiveness of elagolix versus placebo to reduce uterine bleeding associated with uterine fibroids, and to reduce fibroid volum...
Eligibility Criteria
Inclusion
- Subject is a pre-menopausal female 20 to 49 years of age.
- Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound assessed by a central reader and verification that a fibroid present met the following criteria:
- At least 1 fibroid with diameter ≥ 2 cm (longest diameter), or multiple small fibroids with a total uterine volume of ≥ 200 cm³ to ≤ 2,500 cm³ (approximately 22 weeks' gestation) as documented by a centrally read ultrasound.
- Only intramural, submucosal non-pedunculated, and subserosal fibroids qualified subjects for enrollment (intracavitary pedunculated fibroids were exclusionary).
- Ultrasound procedures were performed during the Screening Period, and subjects were not randomized until the investigator reviewed the central reader results verifying the inclusion requirements.
- Subject has a history of regular menstrual cycles between 24 to 35 days.
- Subject has heavy uterine bleeding associated with uterine fibroids as evidenced by blood loss \> 80 mL during 2 screening menstrual cycles, measured by the alkaline hematin method.
Exclusion
- Subject has had a myomectomy, uterine artery embolization, or high intensity focused ultrasound for fibroid destruction within 1 year prior to randomization or any history of endometrial ablation.
- 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), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes.
- Subject has a history of clinically significant condition(s) including but not limited to:
- Endometriosis
- Epilepsy or seizures
- Type 1 diabetes
- Any cancer (except basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy
Key Trial Info
Start Date :
September 8 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2014
Estimated Enrollment :
271 Patients enrolled
Trial Details
Trial ID
NCT01441635
Start Date
September 8 2011
End Date
May 17 2014
Last Update
July 13 2021
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