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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 : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
Myovant Sciences GmbH

Study Description
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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).

Condition or disease Intervention/treatment Phase
Heavy Menstrual Bleeding Uterine Fibroid Drug: Relugolix Drug: Estradiol/norethindrone acetate Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 477 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open-Label Extension
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Primary Completion Date : January 21, 2020
Estimated Study Completion Date : March 31, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Relugolix plus E2/NETA
Relugolix co-administered with E2/NETA for 28 weeks.
 Drug: Relugolix
Relugolix 40-mg tablet administered orally once daily
Other Name: 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 Name: E2/NETA, low-dose hormonal add-back


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. Change From Parent Study Baseline In European Quality Of Life Five Dimension Five Level At Week 52 [ Time Frame: Parent Study Baseline, Week 52 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Myovant Sciences GmbH
Investigators
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Study Director: Myovant Medical Monitor Myovant Sciences
More Information
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Responsible Party: Myovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT03412890    
Other Study ID Numbers: MVT-601-3003
2017-003310-74 ( EudraCT Number )
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Myovant Sciences GmbH:
Uterine Fibroid
Heavy Menstrual Bleeding
Menstrual Blood Volume
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Menorrhagia
Hemorrhage
Pathologic Processes
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Uterine Hemorrhage
Uterine Diseases
 Menstruation Disturbances
Norethindrone
Norethindrone Acetate
Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral