Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Ut… (NCT01817530) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
571 participantsStarted 2013-04-08
Plain-language 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 bleeding in premenopausal women 18 to 51 years of age with uterine fibroids.
Who can participate
Age range18 Years – 51 Years
SexFEMALE
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Inclusion Criteria:
* 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 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, 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
What they're measuring
1
Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month
Timeframe: Baseline, Final Month (last 28 days of treatment)