LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
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|ClinicalTrials.gov Identifier: NCT03412890|
Recruitment Status : Enrolling by invitation
First Posted : January 29, 2018
Last Update Posted : January 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Heavy Menstrual Bleeding Uterine Fibroid||Drug: Relugolix Drug: Low-Dose Hormonal Add-Back||Phase 3|
This study is an international phase 3 open-label, single-arm, long-term efficacy and safety extension study that will enroll eligible patients who have completed their participation in one of the phase 3 randomized, double-blind, placebo-controlled parent studies, MVT-601-3001 (LIBERTY 1 - NCT03049735) or MVT-601-3002 (LIBERTY 2 - NCT 03103087). All patients will receive relugolix 40 mg once daily co-administered with low-dose estradiol (1.0 mg) and norethindrone acetate (0.5 mg) for up to 28 weeks.
Approximately 600 women with heavy menstrual bleeding associated with uterine fibroids will be enrolled, after having completed a 24-week treatment period in one of the parent studies. The objectives of the study are to evaluate long-term efficacy and safety through up to 52 weeks of treatment (including treatment during the parent study) of relugolix co-administered with low-dose estradiol/norethindrone acetate.
Screening and baseline procedures will be done at the same visit for this extension study (referred to as the "Week 24/Baseline Visit"), which coincides with the Week 24 visit from the parent study, and will be defined as the date of completion of the last Week 24 procedure in the parent study. Patients will have received their last dose of study drug in the parent study on the day prior to the Week 24/Baseline Visit and will receive their first dose of study drug for this extension study in the clinic after the patient is determined to be eligible for this extension study and has provided informed consent to participate. The administration of the first dose of study drug for MVT-601-3003 will define enrollment into this study. Study participants will then take the open-label study treatment orally once daily for 28 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open-Label Extension|
|Masking:||None (Open Label)|
|Official Title:||LIBERTY EXTENSION: An International Phase 3 Open-Label, Single-Arm, Long-Term Efficacy and Safety Extension Study to Evaluate Relugolix Co-Administered With Low-Dose Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids|
|Actual Study Start Date :||October 19, 2017|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||January 2020|
|Experimental: Relugolix + Low-Dose Hormonal Add-Back||
Relugolix 40 mg tablet administered orally once dailyDrug: Low-Dose Hormonal Add-Back
Over-encapsulated estradiol 1.0 mg and norethindrone acetate 0.5 mg co-formulated tablet, co-administered with relugolix once daily
- Menstrual Blood Loss Volume [ Time Frame: 52 Weeks ]Proportion of women who achieve or maintain a menstrual blood loss volume of <80 mL and at least a 50% reduction from parent study baseline.
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): NCT03412890
|United States, Arizona|
|Mesa, Arizona, United States, 85209|
|United States, Colorado|
|Denver, Colorado, United States, 80209|
|United States, Florida|
|Margate, Florida, United States, 33063|
|United States, Louisiana|
|Metairie, Louisiana, United States, 70001|
|United States, Nevada|
|Las Vegas, Nevada, United States, 89128|
|United States, Ohio|
|Englewood, Ohio, United States, 45322|
|United States, Texas|
|Houston, Texas, United States, 77054|
|Study Director:||Myovant Medical Monitor, MD||Myovant Sciences|