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

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

Sponsors

Lead Sponsor: Myovant Sciences GmbH

Source Myovant Sciences GmbH
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.

Overall Status Active, not recruiting
Start Date October 19, 2017
Completion Date March 31, 2021
Primary Completion Date January 21, 2020
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Responder Rate Based On Reduction In Menstrual Blood Loss (MBL) Volume At Week 52 Week 52
Secondary Outcome
Measure Time Frame
Change From Parent Study Baseline In MBL Volume At Week 52 Parent Study Baseline, Week 52
Proportion Of Women Who Achieve Or Maintain Amenorrhea At Week 52 Week 52
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
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
Change From Parent Study Baseline In Hemoglobin At Week 52 Parent Study Baseline, Week 52
Change From Parent Study Baseline In The Uterine Fibroid Scale-Symptom Severity At Week 52 Parent Study Baseline, Week 52
Change From Parent Study Baseline In The UFS-QoL Subscales And Total Score At Week 52 Parent Study Baseline, Week 52
Change From Parent Study Baseline In The UFS-QoL Bleeding And Pelvic Discomfort Scale Score At Week 52 Parent Study Baseline, Week 52
Change From Parent Study Baseline In Uterine Volume At Week 52 Parent Study Baseline, Week 52
Change From Parent Study Baseline In Uterine Fibroid Volume At Week 52 Parent Study Baseline, Week 52
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
Change From Parent Study Baseline In Pre-dose Serum E2 Concentrations At Week 52 Parent Study Baseline, Week 52
Change From Parent Study Baseline In European Quality Of Life Five Dimension Five Level At Week 52 Parent Study Baseline, Week 52
Enrollment 477
Condition
Intervention

Intervention Type: Drug

Intervention Name: Relugolix

Description: Relugolix 40-mg tablet administered orally once daily

Arm Group Label: Relugolix plus E2/NETA

Other Name: MVT-601, TAK-385

Intervention Type: Drug

Intervention Name: Estradiol/norethindrone acetate

Description: Capsule containing co-formulated tablet of E2 (1.0 mg) and NETA (0.5 mg) administered orally once daily

Arm Group Label: Relugolix plus E2/NETA

Other Name: E2/NETA, low-dose hormonal add-back

Eligibility

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).

Gender: Female

Minimum Age: 18 Years

Maximum Age: 50 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Myovant Medical Monitor Study Director Myovant Sciences
Location
Facility:
Andalusia | Andalusia, Alabama, 36420, United States
Birmingham | Birmingham, Alabama, 35205, United States
Mobile | Mobile, Alabama, 36608, United States
Mesa | Mesa, Arizona, 85209, United States
Tucson | Tucson, Arizona, 85712, United States
Little Rock | Little Rock, Arkansas, 72205, United States
Canoga Park | Canoga Park, California, 91303, United States
Huntington Beach | Huntington Beach, California, 92647, United States
La Mesa | La Mesa, California, 91942, United States
Long Beach | Long Beach, California, 90806, United States
Los Angeles | Los Angeles, California, 90036, United States
Los Angeles | Los Angeles, California, 90057, United States
Norwalk | Norwalk, California, 90650, United States
Panorama | Panorama City, California, 91402, United States
San Diego | San Diego, California, 92108, United States
San Diego | San Diego, California, 92111, United States
Denver | Denver, Colorado, 80209, United States
Lakewood | Lakewood, Colorado, 80228, United States
Washington | Washington, District of Columbia, 20036, United States
Aventura | Aventura, Florida, 33180, United States
Clearwater | Clearwater, Florida, 33759, United States
DeLand | DeLand, Florida, 32720, United States
Ft. Lauderdale | Fort Lauderdale, Florida, 33316, United States
Fort Myers | Fort Myers, Florida, 33912, United States
Hialeah | Hialeah, Florida, 33016, United States
Jacksonville | Jacksonville, Florida, 32207, United States
Jupiter | Jupiter, Florida, 33458, United States
Loxahatchee | Loxahatchee Groves, Florida, 33470, United States
Margate | Margate, Florida, 33063, United States
Miami | Miami, Florida, 33126, United States
Miami | Miami, Florida, 33155, United States
Miami | Miami, Florida, 33165, United States
New Port Richey | New Port Richey, Florida, 34652, United States
Orlando | Orlando, Florida, 32808, United States
Oviedo | Oviedo, Florida, 32765, United States
Palm Harbor | Palm Harbor, Florida, 34684, United States
Saint Cloud | Saint Cloud, Florida, 34769, United States
Sarasota | Sarasota, Florida, 34239, United States
Tampa | Tampa, Florida, 33606, United States
Tampa | Tampa, Florida, 33613, United States
West Palm Beach | West Palm Beach, Florida, 33409, United States
Weston | Weston, Florida, 33327, United States
Atlanta | Atlanta, Georgia, 30342, United States
Atlanta | Atlanta, Georgia, 30363, United States
Augusta | Augusta, Georgia, 30912, United States
College Park | College Park, Georgia, 30349, United States
Decatur | Decatur, Georgia, 30034, United States
Duluth | Duluth, Georgia, 30097, United States
Norcross | Norcross, Georgia, 30093, United States
Savannah | Savannah, Georgia, 31406, United States
Chicago | Chicago, Illinois, 60611, United States
Naperville | Naperville, Illinois, 60540, United States
Oakbrook | Oakbrook Terrace, Illinois, 60523, United States
Shawnee | Shawnee Mission, Kansas, 66218, United States
Covington | Covington, Louisiana, 70433, United States
Marrero | Marrero, Louisiana, 70072, United States
Metairie | Metairie, Louisiana, 70001, United States
Metairie | Metairie, Louisiana, 70006, United States
Baltimore | Baltimore, Maryland, 21208, United States
Towson | Towson, Maryland, 21204, United States
Canton | Canton, Michigan, 48187, United States
Detroit | Detroit, Michigan, 48201, United States
Saginaw | Saginaw, Michigan, 48604, United States
Lincoln | Lincoln, Nebraska, 68510, United States
Las Vegas | Las Vegas, Nevada, 89109, United States
Las Vegas | Las Vegas, Nevada, 89113, United States
Las Vegas | Las Vegas, Nevada, 89128, United States
Lawrenceville | Lawrenceville, New Jersey, 08648, United States
Albuquerque | Albuquerque, New Mexico, 87102, United States
Brooklyn | Brooklyn, New York, 11201, United States
New York | New York, New York, 10022, United States
Williamsville | Williamsville, New York, 14221, United States
Durham | Durham, North Carolina, 27713, United States
Raleigh | Raleigh, North Carolina, 27607, United States
Raleigh | Raleigh, North Carolina, 27612, United States
Winston-Salem | Winston-Salem, North Carolina, 27103, United States
Cincinnati | Cincinnati, Ohio, 45212, United States
Cincinnati | Cincinnati, Ohio, 45219, United States
Columbus | Columbus, Ohio, 43231, United States
Englewood | Englewood, Ohio, 45322, United States
Philadelphia | Philadelphia, Pennsylvania, 19104, United States
Bluffton | Bluffton, South Carolina, 29910, United States
Charleston | Charleston, South Carolina, 29406, United States
Columbia | Columbia, South Carolina, 29201, United States
Chattanooga | Chattanooga, Tennessee, 37404, United States
Memphis | Memphis, Tennessee, 38119, United States
Memphis | Memphis, Tennessee, 38120, United States
Beaumont | Beaumont, Texas, 77702, United States
Dallas | Dallas, Texas, 75231, United States
Fort Worth | Fort Worth, Texas, 76104, United States
Houston | Houston, Texas, 77030, United States
Houston | Houston, Texas, 77054, United States
Houston | Houston, Texas, 77074, United States
Longview | Longview, Texas, 75605, United States
San Antonio | San Antonio, Texas, 78229, United States
San Antonio | San Antonio, Texas, 78258, United States
Sugar Land | Sugar Land, Texas, 77479, United States
Webster | Webster, Texas, 77598, United States
Salt Lake City | Salt Lake City, Utah, 84107, United States
Salt Lake City | Salt Lake City, Utah, 84124, United States
Norfolk | Norfolk, Virginia, 23502, United States
Norfolk | Norfolk, Virginia, 23507, United States
Richmond | Richmond, Virginia, 23225, United States
Spokane | Spokane, Washington, 99207, United States
La Louvière | La Louvière, Hainaut, 7100, Belgium
Gent | Gent, Oost-vlaanderen, 9000, Belgium
Brussels | Brussels, 1200, Belgium
Jette | Jette, 1090, Belgium
Santo Andre | Santo André, Santo Andre, 09190-510, Brazil
Santo André | Santo André, SAO Paulo, 09190-510, Brazil
Sao Paulo | São Paulo, Sao Paulo, 01317-000, Brazil
Sao Paulo | São Paulo, Sao Paulo, 04266-010, Brazil
Botucatu | Botucatu, 18618-686, Brazil
Porto Alegre | Porto Alegre, 90035-903, Brazil
Porto Alegre | Porto Alegre, 90510-040, Brazil
Providencia | Providencia, 7510186, Chile
San Ramon | San Ramón, 8880465, Chile
Region Metropolitana | Santiago, 8320165, Chile
Santiago | Santiago, 8360160, Chile
Jihlava | Jihlava, 586 33, Czechia
Olomouc | Olomouc, 772 00, Czechia
Pisek | Písek, 39701, Czechia
Ceské Budejovice | České Budějovice, 370 01, Czechia
Kecskemét | Kecskemét, Bacs-kiskun, 6000, Hungary
Gyula | Gyula, Bekes, 5700, Hungary
Debrecen | Debrecen, Hajdu-bihar, 4024, Hungary
Nyíregyháza | Nyíregyháza, Szabolcs-Szatmar-Bereg, 4400, Hungary
Debrecen | Debrecen, 4025, Hungary
Szentes | Szentes, 6600, Hungary
Catanzaro | Catanzaro, 88100, Italy
Firenze | Firenze, 50134, Italy
Roma | Roma, 00168, Italy
Siena | Siena, 53100, Italy
Torino | Torino, 10126, Italy
Lódz | Lódz, Lodzkie, 90-602, Poland
Lublin | Lublin, Lubelskie, 20-632, Poland
Warszawa | Warszawa, Mazowieckie, 02-201, Poland
Katowice | Katowice, Slaskie, 40-123, Poland
Poznan | Poznań, Wielkopolskie, 60-192, Poland
Szczecin | Szczecin, Zachodniopomorskie, 71-270, Poland
Bialystok | Białystok, 15-464, Poland
Centurion | Centurion, Gauteng, 0157, South Africa
Roodepoort | Roodepoort, Gauteng, 1724, South Africa
Durban | Durban, Kwazulu-natal, 4126, South Africa
Bloemfontein | Bloemfontein, 9301, South Africa
Cape Town | Cape Town, 7405, South Africa
Cape Town | Cape Town, 7500, South Africa
Port Elizabeth | Port Elizabeth, 6001, South Africa
Location Countries

Belgium

Brazil

Chile

Czechia

Hungary

Italy

Poland

South Africa

United States

Verification Date

July 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Relugolix plus E2/NETA

Type: Experimental

Description: Relugolix co-administered with E2/NETA for 28 weeks.

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: Open-Label Extension

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov