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LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03412890
Recruitment Status : Completed
First Posted : January 29, 2018
Last Update Posted : June 9, 2021
Sponsor:
Information provided by (Responsible Party):
Myovant Sciences GmbH

Tracking Information
First Submitted Date  ICMJE January 19, 2018
First Posted Date  ICMJE January 29, 2018
Last Update Posted Date June 9, 2021
Actual Study Start Date  ICMJE October 19, 2017
Actual Primary Completion Date January 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2020)
Responder Rate Based On Reduction In Menstrual Blood Loss (MBL) Volume At Week 52 [ Time Frame: Week 52 ]
Defined as the proportion of women who achieve an MBL volume of < 80 milliliters (mL) and at least a 50% reduction from parent study Baseline to the last 35 days of treatment. MBL volume is measured using the alkaline hematin method.
Original Primary Outcome Measures  ICMJE
 (submitted: January 19, 2018)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2020)
  • Change From Parent Study Baseline In MBL Volume At Week 52 [ Time Frame: Parent Study Baseline, Week 52 ]
    MBL volume is measured using the alkaline hematin method.
  • Proportion Of Women Who Achieve Or Maintain Amenorrhea At Week 52 [ Time Frame: Week 52 ]
    Will be assessed using participant reporting at visit and MBL volume measured using the alkaline hematin method.
  • Proportion Of Women With Hemoglobin Below The Lower Limit Of Normal At Parent Study Baseline Who Achieve An Increase Of At Least 1 Gram/Deciliter (g/dL) From Parent Study Baseline At Week 52 [ Time Frame: Week 52 ]
    Blood samples will be collected from participants for hemoglobin measurements.
  • Proportion Of Women With A Hemoglobin ≤ 10.5 g/dL At Parent Study Baseline Who Achieve An Increase Of > 2 g/dL From Parent Study Baseline At Week 52 [ Time Frame: Week 52 ]
    Blood samples will be collected from participants for hemoglobin measurements.
  • Change From Parent Study Baseline In Hemoglobin At Week 52 [ Time Frame: Parent Study Baseline, Week 52 ]
    Blood samples will be collected from participants for hemoglobin measurements.
  • Change From Parent Study Baseline In The Uterine Fibroid Scale-Symptom Severity At Week 52 [ Time Frame: Parent Study Baseline, Week 52 ]
    Assessed using the Uterine Fibroid Symptom Health-Related Quality of Life (UFS-QoL) Questionnaire.
  • Change From Parent Study Baseline In The UFS-QoL Subscales And Total Score At Week 52 [ Time Frame: Parent Study Baseline, Week 52 ]
    Assessed using the UFS-QoL Questionnaire.
  • Change From Parent Study Baseline In The UFS-QoL Bleeding And Pelvic Discomfort Scale Score At Week 52 [ Time Frame: Parent Study Baseline, Week 52 ]
    Assessed using the UFS-QoL Questionnaire.
  • Change From Parent Study Baseline In Uterine Volume At Week 52 [ Time Frame: Parent Study Baseline, Week 52 ]
    Volume of the uterus will be measured by transvaginal or transabdominal ultrasound.
  • Change From Parent Study Baseline In Uterine Fibroid Volume At Week 52 [ Time Frame: Parent Study Baseline, Week 52 ]
    Volume of the primary uterine fibroid will be measured by transvaginal or transabdominal ultrasound.
  • Percent Change From Parent Study Baseline In Bone Mineral Density (BMD) At The Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52 [ Time Frame: Parent Study Baseline, Week 52 ]
    Assessed by dual-energy X-ray absorptiometry scan.
  • Change From Parent Study Baseline In Pre-dose Serum E2 Concentrations At Week 52 [ Time Frame: Parent Study Baseline, Week 52 ]
    Blood samples will be collected from participants for E2 measurements.
  • Change From Parent Study Baseline In European Quality Of Life Five Dimension Five Level At Week 52 [ Time Frame: Parent Study Baseline, Week 52 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Official Title  ICMJE 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
Brief Summary The purpose of this study is to determine the long-term efficacy and safety of relugolix 40 milligrams (mg) once daily co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) for 28 weeks on heavy menstrual bleeding associated with uterine fibroids in participants who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3001 or MVT-601-3002).
Detailed Description

This study is an international phase 3 open-label, single-arm, long-term efficacy and safety extension study that will enroll eligible participants 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 participants will receive relugolix 40 mg orally once daily co-administered with low-dose E2 (1.0 mg) and NETA (0.5 mg) for 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 E2/NETA.

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. Participants 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 participant 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Open-Label Extension
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Heavy Menstrual Bleeding
  • Uterine Fibroid
Intervention  ICMJE
  • Drug: Relugolix
    Relugolix 40-mg tablet administered orally once daily
    Other Names:
    • MVT-601
    • TAK-385
  • Drug: Estradiol/norethindrone acetate
    Capsule containing co-formulated tablet of E2 (1.0 mg) and NETA (0.5 mg) administered orally once daily
    Other Names:
    • E2/NETA
    • Low-dose hormonal add-back
Study Arms  ICMJE Experimental: Relugolix plus E2/NETA
Relugolix co-administered with E2/NETA for 28 weeks.
Interventions:
  • Drug: Relugolix
  • Drug: Estradiol/norethindrone acetate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2020)
477
Original Estimated Enrollment  ICMJE
 (submitted: January 19, 2018)
600
Actual Study Completion Date  ICMJE January 13, 2021
Actual Primary Completion Date January 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

1. Completed 24 weeks of study drug treatment and study participation in either parent study, MVT-601-3001 or MVT-601-3002

Key Exclusion Criteria:

  1. Has undergone myomectomy, ultrasound-guided laparoscopic radiofrequency ablation, or any other surgical procedure for fibroids, uterine artery embolization, magnetic resonance-guided focused ultrasound for fibroids, or endometrial ablation for abnormal uterine bleeding at any time during the parent study (MVT-601-3001 or MVT-601-3002)
  2. Met a withdrawal criterion in the parent study (MVT-601-3001 or MVT-601-3002).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Brazil,   Chile,   Czechia,   Hungary,   Italy,   Poland,   South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03412890
Other Study ID Numbers  ICMJE MVT-601-3003
2017-003310-74 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Myovant Sciences GmbH
Study Sponsor  ICMJE Myovant Sciences GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Myovant Medical Monitor Myovant Sciences
PRS Account Myovant Sciences GmbH
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP