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 : May 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Heavy Menstrual Bleeding Uterine Fibroid||Drug: Relugolix Drug: Estradiol/norethindrone acetate||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 :||February 28, 2020|
|Estimated Study Completion Date :||July 30, 2020|
Experimental: Relugolix plus E2/NETA
Relugolix 40 mg co-administered with estradiol (1.0 mg) and norethindrone acetate (0.5 mg) for up to 28 weeks
Relugolix 40 mg tablet administered orally once daily
Other Name: TAK-385
Drug: Estradiol/norethindrone acetate
Capsule containing co-formulated tablet of estradiol 1.0 mg and norethindrone acetate 0.5 mg administered orally once daily
Other Name: E2/NETA, low-dose hormonal add-back
- Responder rate based on reduction in menstrual blood loss (MBL) volume [ Time Frame: from Parent study Baseline up to last 35 days of treatment, anticipated to be up to 52 weeks ]Defined as the proportion of women who achieve a MBL volume of < 80 mL and a ≥ 50% reduction from parent study Baseline MBL volume over the last 35 days of treatment. MBL volume is measured using the alkaline hematin method.
- Time to MBL response [ Time Frame: up to 52 weeks ]Defined as the time to achieve a MBL volume of < 80 mL and a ≥ 50% reduction from parent study Baseline MBL volume as measured by the alkaline hematin method.
- Change in MBL volume [ Time Frame: from parent study Baseline up to Week 52 ]MBL volume is measured using the alkaline hematin method.
- Proportion of women with suppression of bleeding [ Time Frame: from parent study Baseline up to last 35 days of treatment, anticipated to be up to 52 weeks ]Will be assessed using patient daily diary and MBL volume measured using the alkaline hematin method.
- Change in hemoglobin concentration [ Time Frame: from parent study Baseline up to Week 52 ]Blood samples will be collected from participants for hemoglobin measurements.
- Change in uterine volume [ Time Frame: from parent study Baseline up to Week 52 ]Volume of the uterus will be measured by transvaginal or transabdominal ultrasound.
- Change in primary fibroid volume [ Time Frame: from parent study Baseline up to Week 52 ]Volume of the primary fibroid will be measured by transvaginal or transabdominal ultrasound.
- Change in impact on quality of life [ Time Frame: from parent study Baseline up to Week 52 ]Assessed using the Uterine Fibroid Symptom Health-Related Quality of Life Questionnaire (UFS-QOL).
- Bone Mineral Density (BMD) [ Time Frame: from parent study Baseline up to Week 52 ]Assessed by dual-energy X-ray absorptiometry (DXA) scan.
- The number and percentage of participants with adverse events (AE) as a measure of safety and tolerability [ Time Frame: up to 52 weeks ]Assessed by frequency and severity of AEs and serious AEs.
- Serum estradiol concentrations [ Time Frame: up to 52 weeks ]Blood samples will be collected from participants for estradiol measurements.
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
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|Study Director:||Myovant Medical Monitor, MD||Myovant Sciences|