EUCTR2013-000082-37-GB
Active, not recruiting
Phase 1
A Phase 2b Study to Evaluate the Safety and Efficacy of Elagolix in Premenopausal Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids
ConditionsHeavy menstrual bleeding associated with uterine fibroidsMedDRA version: 18.0 Level: LLT Classification code 10046784 Term: Uterine fibroids System Organ Class: 100000004864Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Heavy menstrual bleeding associated with uterine fibroids
- Sponsor
- Abbvie Deutschland GmbH & Co. KG
- Enrollment
- 567
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is pre\-menopausal female 18\-51 years old;
- •Subject has diagnosis of uterine fibroids documented by pelvic ultrasound;
- •Subject has heavy menstrual bleeding associated with uterine fibroids
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 520
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •\- 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), 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: \* Symptomatic Endometriosis \* Epilepsy or seizures \* Type 1 diabetes \* Chronic kidney disease \* Any history of cancer or any type (except treated basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy.
Outcomes
Primary Outcomes
Not specified
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