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

Sponsor
Myovant Sciences GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT03412890
Collaborator
(none)
477
Enrollment
150
Locations
1
Arm
38.8
Actual Duration (Months)
3.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
Actual Enrollment :
477 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Open-Label ExtensionOpen-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 :
Oct 19, 2017
Actual Primary Completion Date :
Jan 21, 2020
Actual Study Completion Date :
Jan 13, 2021

Arms and Interventions

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 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Responder Rate Based On Reduction In Menstrual Blood Loss (MBL) Volume At Week 52 [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 [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 [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 [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 [Week 52]

      Blood samples will be collected from participants for hemoglobin measurements.

    5. Change From Parent Study Baseline In Hemoglobin At Week 52 [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 [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 [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 [Parent Study Baseline, Week 52]

      Assessed using the UFS-QoL Questionnaire.

    9. Change From Parent Study Baseline In Uterine Volume At Week 52 [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 [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 [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 [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 [Parent Study Baseline, Week 52]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Andalusia Andalusia Alabama United States 36420
    2 Birmingham Birmingham Alabama United States 35205
    3 Mobile Mobile Alabama United States 36608
    4 Mesa Mesa Arizona United States 85209
    5 Tucson Tucson Arizona United States 85712
    6 Little Rock Little Rock Arkansas United States 72204
    7 Canoga Park Canoga Park California United States 91303
    8 Huntington Beach Huntington Beach California United States 92647
    9 La Mesa La Mesa California United States 91942
    10 Long Beach Long Beach California United States 90806
    11 Los Angeles Los Angeles California United States 90036
    12 Los Angeles Los Angeles California United States 90057
    13 Norwalk Norwalk California United States 90650
    14 Panorama Panorama City California United States 91402
    15 San Diego San Diego California United States 92108
    16 San Diego San Diego California United States 92111
    17 Denver Denver Colorado United States 80209
    18 Lakewood Lakewood Colorado United States 80228
    19 Washington Washington District of Columbia United States 20036
    20 Aventura Aventura Florida United States 33180
    21 Clearwater Clearwater Florida United States 33759
    22 DeLand DeLand Florida United States 32720
    23 Ft. Lauderdale Fort Lauderdale Florida United States 33316
    24 Fort Myers Fort Myers Florida United States 33912
    25 Hialeah Hialeah Florida United States 33016
    26 Jacksonville Jacksonville Florida United States 32207
    27 Jupiter Jupiter Florida United States 33458
    28 Loxahatchee Loxahatchee Groves Florida United States 33470
    29 Margate Margate Florida United States 33063
    30 Miami Miami Florida United States 33126
    31 Miami Miami Florida United States 33155
    32 Miami Miami Florida United States 33165
    33 New Port Richey New Port Richey Florida United States 34652
    34 Orlando Orlando Florida United States 32808
    35 Oviedo Oviedo Florida United States 32765
    36 Palm Harbor Palm Harbor Florida United States 34684
    37 Saint Cloud Saint Cloud Florida United States 34769
    38 Sarasota Sarasota Florida United States 34239
    39 Tampa Tampa Florida United States 33606
    40 Tampa Tampa Florida United States 33613
    41 West Palm Beach West Palm Beach Florida United States 33409
    42 Weston Weston Florida United States 33327
    43 Atlanta Atlanta Georgia United States 30342
    44 Atlanta Atlanta Georgia United States 30363
    45 Augusta Augusta Georgia United States 30904
    46 College Park College Park Georgia United States 30349
    47 Decatur Decatur Georgia United States 30034
    48 Duluth Duluth Georgia United States 30097
    49 Norcross Norcross Georgia United States 30093
    50 Savannah Savannah Georgia United States 31406
    51 Chicago Chicago Illinois United States 60611
    52 Naperville Naperville Illinois United States 60540
    53 Oakbrook Oakbrook Terrace Illinois United States 60523
    54 Shawnee Shawnee Mission Kansas United States 66218
    55 Covington Covington Louisiana United States 70433
    56 Marrero Marrero Louisiana United States 70072
    57 Metairie Metairie Louisiana United States 70001
    58 Metairie Metairie Louisiana United States 70006
    59 Baltimore Baltimore Maryland United States 21208
    60 Towson Towson Maryland United States 21204
    61 Canton Canton Michigan United States 48187
    62 Detroit Detroit Michigan United States 48201
    63 Saginaw Saginaw Michigan United States 48604
    64 Lincoln Lincoln Nebraska United States 68510
    65 Las Vegas Las Vegas Nevada United States 89109
    66 Las Vegas Las Vegas Nevada United States 89113
    67 Las Vegas Las Vegas Nevada United States 89128
    68 Lawrenceville Lawrenceville New Jersey United States 08648
    69 Albuquerque Albuquerque New Mexico United States 87102
    70 Brooklyn Brooklyn New York United States 11201
    71 New York New York New York United States 10022
    72 Williamsville Williamsville New York United States 14221
    73 Durham Durham North Carolina United States 27713
    74 Raleigh Raleigh North Carolina United States 27607
    75 Raleigh Raleigh North Carolina United States 27612
    76 Winston-Salem Winston-Salem North Carolina United States 27103
    77 Cincinnati Cincinnati Ohio United States 45212
    78 Cincinnati Cincinnati Ohio United States 45219
    79 Columbus Columbus Ohio United States 43231
    80 Englewood Englewood Ohio United States 45322
    81 Philadelphia Philadelphia Pennsylvania United States 19104
    82 Bluffton Bluffton South Carolina United States 29910
    83 Charleston Charleston South Carolina United States 29406
    84 Columbia Columbia South Carolina United States 29201
    85 Chattanooga Chattanooga Tennessee United States 37404
    86 Memphis Memphis Tennessee United States 38119
    87 Memphis Memphis Tennessee United States 38120
    88 Beaumont Beaumont Texas United States 77702
    89 Dallas Dallas Texas United States 75231
    90 Fort Worth Fort Worth Texas United States 76104
    91 Houston Houston Texas United States 77030
    92 Houston Houston Texas United States 77054
    93 Houston Houston Texas United States 77074
    94 Longview Longview Texas United States 75605
    95 San Antonio San Antonio Texas United States 78229
    96 San Antonio San Antonio Texas United States 78258
    97 Sugar Land Sugar Land Texas United States 77479
    98 Webster Webster Texas United States 77598
    99 Salt Lake City Salt Lake City Utah United States 84107
    100 Salt Lake City Salt Lake City Utah United States 84124
    101 Norfolk Norfolk Virginia United States 23502
    102 Norfolk Norfolk Virginia United States 23507
    103 Richmond Richmond Virginia United States 23225
    104 Spokane Spokane Washington United States 99207
    105 La Louvière La Louvière Hainaut Belgium 7100
    106 Gent Gent Oost-vlaanderen Belgium 9000
    107 Brussels Brussels Belgium 1200
    108 Jette Jette Belgium 1090
    109 Santo Andre Santo André Santo Andre Brazil 09190-510
    110 Santo André Santo André SAO Paulo Brazil 09190-510
    111 São Bernardo Do Campo São Bernardo Do Campo Sao Paulo Brazil 09715-090
    112 Sao Paulo São Paulo Sao Paulo Brazil 01317-000
    113 Sao Paulo São Paulo Sao Paulo Brazil 04266-010
    114 Botucatu Botucatu Brazil 18618-686
    115 Porto Alegre Porto Alegre Brazil 90035-903
    116 Porto Alegre Porto Alegre Brazil 90510-040
    117 Providencia Providencia Chile 7510186
    118 San Ramon San Ramón Chile 8880465
    119 Region Metropolitana Santiago Chile 8320165
    120 Santiago Santiago Chile 8360160
    121 Jihlava Jihlava Czechia 586 33
    122 Olomouc Olomouc Czechia 772 00
    123 Pisek Písek Czechia 39701
    124 Ceské Budejovice České Budějovice Czechia 370 01
    125 Kecskemét Kecskemét Bacs-kiskun Hungary 6000
    126 Gyula Gyula Bekes Hungary 5700
    127 Debrecen Debrecen Hajdu-bihar Hungary 4024
    128 Nyíregyháza Nyíregyháza Szabolcs-Szatmar-Bereg Hungary 4400
    129 Debrecen Debrecen Hungary 4025
    130 Szentes Szentes Hungary 6600
    131 Catanzaro Catanzaro Italy 88100
    132 Firenze Firenze Italy 50134
    133 Roma Roma Italy 00168
    134 Siena Siena Italy 53100
    135 Torino Torino Italy 10126
    136 Lódz Lódz Lodzkie Poland 90-602
    137 Lublin Lublin Lubelskie Poland 20-632
    138 Warszawa Warszawa Mazowieckie Poland 02-201
    139 Katowice Katowice Slaskie Poland 40-123
    140 Poznan Poznań Wielkopolskie Poland 60-192
    141 Skórzewo Skórzewo Wielkopolskie Poland 60-185
    142 Szczecin Szczecin Zachodniopomorskie Poland 71-270
    143 Bialystok Białystok Poland 15-464
    144 Centurion Centurion Gauteng South Africa 0157
    145 Roodepoort Roodepoort Gauteng South Africa 1724
    146 Durban Durban Kwazulu-natal South Africa 4001
    147 Bloemfontein Bloemfontein South Africa 9301
    148 Cape Town Cape Town South Africa 7405
    149 Cape Town Cape Town South Africa 7500
    150 Port Elizabeth Port Elizabeth South Africa 6001

    Sponsors and Collaborators

    • Myovant Sciences GmbH

    Investigators

    • Study Director: Myovant Medical Monitor, Myovant Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Myovant Sciences GmbH
    ClinicalTrials.gov Identifier:
    NCT03412890
    Other Study ID Numbers:
    • MVT-601-3003
    • 2017-003310-74
    First Posted:
    Jan 29, 2018
    Last Update Posted:
    Jun 9, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Leiomyoma
    Myofibroma
    Menorrhagia
    Hemorrhage
    Norethindrone
    Norethindrone Acetate
    Estradiol
    Relugolix

    Study Results

    No Results Posted as of Jun 9, 2021