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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 : Active, not recruiting
First Posted : January 29, 2018
Last Update Posted : September 10, 2019
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 September 10, 2019
Actual Study Start Date  ICMJE October 19, 2017
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2018)
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.
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 Complete list of historical versions of study NCT03412890 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2018)
  • 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.
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 of Relugolix 40 mg once daily co-administered with low-dose estradiol and norethindrone acetate for up to 52 weeks, on heavy menstrual bleeding associated with uterine fibroids in patients 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 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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 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
Study Arms  ICMJE 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
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 19, 2018)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 30, 2020
Estimated Primary Completion Date February 28, 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 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 No
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: Undecided
Responsible Party Myovant Sciences GmbH
Study Sponsor  ICMJE Myovant Sciences GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Myovant Medical Monitor, MD Myovant Sciences
PRS Account Myovant Sciences GmbH
Verification Date September 2019

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