An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
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|ClinicalTrials.gov Identifier: NCT02925494|
Recruitment Status : Active, not recruiting
First Posted : October 6, 2016
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Uterine Fibroids Heavy Menstrual Bleeding||Drug: Estradiol/Norethindrone Acetate Drug: Elagolix||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||433 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids|
|Actual Study Start Date :||September 14, 2016|
|Actual Primary Completion Date :||May 7, 2018|
|Estimated Study Completion Date :||March 29, 2019|
Experimental: Elagolix plus Estradiol/Norethindrone Acetate (E2/NETA)
Participants receiving Elagolix plus E2/NETA
Drug: Estradiol/Norethindrone Acetate
Participants receiving Elagolix
- Percentage of Responders based on menstrual blood loss volume reduction [ Time Frame: From Month 0 (Baseline in Pivotal Study) to Final Month of Treatment Period (up through 12 months) ]Assessed using alkaline hematin methodology.
- Change in Menstrual Blood Loss (MBL) Volume [ Time Frame: From Month 0 to Final Month (last 28 days of treatment) ]Assessed using alkaline hematin methodology
- Percentage of participants with increase in Hemoglobin [ Time Frame: Month 0 to Month 6 ]This assesses the concentration of hemoglobin.
- Percentage of participants with suppression of bleeding [ Time Frame: Up to Month 6 (during 6-Month treatment period) ]Suppression of bleeding is defined as having no days of bleeding (spotting is allowed) during a 28-day interval.
- Change in MBL Volume by Month [ Time Frame: Every Month From Month 0 (Baseline) through Month 6 ]Assessed using alkaline hematin methodology
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925494
Show 125 Study Locations
|Study Director:||AbbVie Inc.||AbbVie|