Uterine Fibroid Clinical Trial
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
Verified date | March 2021 |
Source | Myovant Sciences GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 477 |
Est. completion date | January 13, 2021 |
Est. primary completion date | January 21, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Belgium | Brussels | Brussels | |
Belgium | Gent | Gent | Oost-vlaanderen |
Belgium | Jette | Jette | |
Belgium | La Louvière | La Louvière | Hainaut |
Brazil | Botucatu | Botucatu | |
Brazil | Porto Alegre | Porto Alegre | |
Brazil | Porto Alegre | Porto Alegre | |
Brazil | Santo Andre | Santo André | Santo Andre |
Brazil | Santo André | Santo André | SAO Paulo |
Brazil | São Bernardo Do Campo | São Bernardo Do Campo | Sao Paulo |
Brazil | Sao Paulo | São Paulo | Sao Paulo |
Brazil | Sao Paulo | São Paulo | Sao Paulo |
Chile | Providencia | Providencia | |
Chile | San Ramon | San Ramón | |
Chile | Region Metropolitana | Santiago | |
Chile | Santiago | Santiago | |
Czechia | Ceské Budejovice | Ceské Budejovice | |
Czechia | Jihlava | Jihlava | |
Czechia | Olomouc | Olomouc | |
Czechia | Pisek | Písek | |
Hungary | Debrecen | Debrecen | Hajdu-bihar |
Hungary | Debrecen | Debrecen | |
Hungary | Gyula | Gyula | Bekes |
Hungary | Kecskemét | Kecskemét | Bacs-kiskun |
Hungary | Nyíregyháza | Nyíregyháza | Szabolcs-Szatmar-Bereg |
Hungary | Szentes | Szentes | |
Italy | Catanzaro | Catanzaro | |
Italy | Firenze | Firenze | |
Italy | Roma | Roma | |
Italy | Siena | Siena | |
Italy | Torino | Torino | |
Poland | Bialystok | Bialystok | |
Poland | Katowice | Katowice | Slaskie |
Poland | Lódz | Lódz | Lodzkie |
Poland | Lublin | Lublin | Lubelskie |
Poland | Poznan | Poznan | Wielkopolskie |
Poland | Skórzewo | Skórzewo | Wielkopolskie |
Poland | Szczecin | Szczecin | Zachodniopomorskie |
Poland | Warszawa | Warszawa | Mazowieckie |
South Africa | Bloemfontein | Bloemfontein | |
South Africa | Cape Town | Cape Town | |
South Africa | Cape Town | Cape Town | |
South Africa | Centurion | Centurion | Gauteng |
South Africa | Durban | Durban | Kwazulu-natal |
South Africa | Port Elizabeth | Port Elizabeth | |
South Africa | Roodepoort | Roodepoort | Gauteng |
United States | Albuquerque | Albuquerque | New Mexico |
United States | Andalusia | Andalusia | Alabama |
United States | Atlanta | Atlanta | Georgia |
United States | Atlanta | Atlanta | Georgia |
United States | Augusta | Augusta | Georgia |
United States | Aventura | Aventura | Florida |
United States | Baltimore | Baltimore | Maryland |
United States | Beaumont | Beaumont | Texas |
United States | Birmingham | Birmingham | Alabama |
United States | Bluffton | Bluffton | South Carolina |
United States | Brooklyn | Brooklyn | New York |
United States | Canoga Park | Canoga Park | California |
United States | Canton | Canton | Michigan |
United States | Charleston | Charleston | South Carolina |
United States | Chattanooga | Chattanooga | Tennessee |
United States | Chicago | Chicago | Illinois |
United States | Cincinnati | Cincinnati | Ohio |
United States | Cincinnati | Cincinnati | Ohio |
United States | Clearwater | Clearwater | Florida |
United States | College Park | College Park | Georgia |
United States | Columbia | Columbia | South Carolina |
United States | Columbus | Columbus | Ohio |
United States | Covington | Covington | Louisiana |
United States | Dallas | Dallas | Texas |
United States | Decatur | Decatur | Georgia |
United States | DeLand | DeLand | Florida |
United States | Denver | Denver | Colorado |
United States | Detroit | Detroit | Michigan |
United States | Duluth | Duluth | Georgia |
United States | Durham | Durham | North Carolina |
United States | Englewood | Englewood | Ohio |
United States | Ft. Lauderdale | Fort Lauderdale | Florida |
United States | Fort Myers | Fort Myers | Florida |
United States | Fort Worth | Fort Worth | Texas |
United States | Hialeah | Hialeah | Florida |
United States | Houston | Houston | Texas |
United States | Houston | Houston | Texas |
United States | Houston | Houston | Texas |
United States | Huntington Beach | Huntington Beach | California |
United States | Jacksonville | Jacksonville | Florida |
United States | Jupiter | Jupiter | Florida |
United States | La Mesa | La Mesa | California |
United States | Lakewood | Lakewood | Colorado |
United States | Las Vegas | Las Vegas | Nevada |
United States | Las Vegas | Las Vegas | Nevada |
United States | Las Vegas | Las Vegas | Nevada |
United States | Lawrenceville | Lawrenceville | New Jersey |
United States | Lincoln | Lincoln | Nebraska |
United States | Little Rock | Little Rock | Arkansas |
United States | Long Beach | Long Beach | California |
United States | Longview | Longview | Texas |
United States | Los Angeles | Los Angeles | California |
United States | Los Angeles | Los Angeles | California |
United States | Loxahatchee | Loxahatchee Groves | Florida |
United States | Margate | Margate | Florida |
United States | Marrero | Marrero | Louisiana |
United States | Memphis | Memphis | Tennessee |
United States | Memphis | Memphis | Tennessee |
United States | Mesa | Mesa | Arizona |
United States | Metairie | Metairie | Louisiana |
United States | Metairie | Metairie | Louisiana |
United States | Miami | Miami | Florida |
United States | Miami | Miami | Florida |
United States | Miami | Miami | Florida |
United States | Mobile | Mobile | Alabama |
United States | Naperville | Naperville | Illinois |
United States | New Port Richey | New Port Richey | Florida |
United States | New York | New York | New York |
United States | Norcross | Norcross | Georgia |
United States | Norfolk | Norfolk | Virginia |
United States | Norfolk | Norfolk | Virginia |
United States | Norwalk | Norwalk | California |
United States | Oakbrook | Oakbrook Terrace | Illinois |
United States | Orlando | Orlando | Florida |
United States | Oviedo | Oviedo | Florida |
United States | Palm Harbor | Palm Harbor | Florida |
United States | Panorama | Panorama City | California |
United States | Philadelphia | Philadelphia | Pennsylvania |
United States | Raleigh | Raleigh | North Carolina |
United States | Raleigh | Raleigh | North Carolina |
United States | Richmond | Richmond | Virginia |
United States | Saginaw | Saginaw | Michigan |
United States | Saint Cloud | Saint Cloud | Florida |
United States | Salt Lake City | Salt Lake City | Utah |
United States | Salt Lake City | Salt Lake City | Utah |
United States | San Antonio | San Antonio | Texas |
United States | San Antonio | San Antonio | Texas |
United States | San Diego | San Diego | California |
United States | San Diego | San Diego | California |
United States | Sarasota | Sarasota | Florida |
United States | Savannah | Savannah | Georgia |
United States | Shawnee | Shawnee Mission | Kansas |
United States | Spokane | Spokane | Washington |
United States | Sugar Land | Sugar Land | Texas |
United States | Tampa | Tampa | Florida |
United States | Tampa | Tampa | Florida |
United States | Towson | Towson | Maryland |
United States | Tucson | Tucson | Arizona |
United States | Washington | Washington | District of Columbia |
United States | Webster | Webster | Texas |
United States | West Palm Beach | West Palm Beach | Florida |
United States | Weston | Weston | Florida |
United States | Williamsville | Williamsville | New York |
United States | Winston-Salem | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Myovant Sciences GmbH |
United States, Belgium, Brazil, Chile, Czechia, Hungary, Italy, Poland, South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Responder Rate Based On Reduction In Menstrual Blood Loss (MBL) Volume At 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. | Week 52 | |
Secondary | Change From Parent Study Baseline In MBL Volume At Week 52 | MBL volume is measured using the alkaline hematin method. | Parent Study Baseline, Week 52 | |
Secondary | Proportion Of Women Who Achieve Or Maintain Amenorrhea At Week 52 | Will be assessed using participant reporting at visit and MBL volume measured using the alkaline hematin method. | Week 52 | |
Secondary | 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 | Blood samples will be collected from participants for hemoglobin measurements. | Week 52 | |
Secondary | 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 | Blood samples will be collected from participants for hemoglobin measurements. | Week 52 | |
Secondary | Change From Parent Study Baseline In Hemoglobin At Week 52 | Blood samples will be collected from participants for hemoglobin measurements. | Parent Study Baseline, Week 52 | |
Secondary | Change From Parent Study Baseline In The Uterine Fibroid Scale-Symptom Severity At Week 52 | Assessed using the Uterine Fibroid Symptom Health-Related Quality of Life (UFS-QoL) Questionnaire. | Parent Study Baseline, Week 52 | |
Secondary | Change From Parent Study Baseline In The UFS-QoL Subscales And Total Score At Week 52 | Assessed using the UFS-QoL Questionnaire. | Parent Study Baseline, Week 52 | |
Secondary | Change From Parent Study Baseline In The UFS-QoL Bleeding And Pelvic Discomfort Scale Score At Week 52 | Assessed using the UFS-QoL Questionnaire. | Parent Study Baseline, Week 52 | |
Secondary | Change From Parent Study Baseline In Uterine Volume At Week 52 | Volume of the uterus will be measured by transvaginal or transabdominal ultrasound. | Parent Study Baseline, Week 52 | |
Secondary | Change From Parent Study Baseline In Uterine Fibroid Volume At Week 52 | Volume of the primary uterine fibroid will be measured by transvaginal or transabdominal ultrasound. | Parent Study Baseline, Week 52 | |
Secondary | 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 | Assessed by dual-energy X-ray absorptiometry scan. | Parent Study Baseline, Week 52 | |
Secondary | Change From Parent Study Baseline In Pre-dose Serum E2 Concentrations At Week 52 | Blood samples will be collected from participants for E2 measurements. | Parent Study Baseline, Week 52 | |
Secondary | Change From Parent Study Baseline In European Quality Of Life Five Dimension Five Level At Week 52 | Parent Study Baseline, Week 52 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04073485 -
Microwave Ablation for Uterine Fibroids
|
N/A | |
Recruiting |
NCT04519593 -
ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma
|
N/A | |
Recruiting |
NCT01239641 -
High Intensity Focused Ultrasound Ablation Virus Myomectomy to Treat Uterine Fibroids
|
Phase 4 | |
Recruiting |
NCT04748978 -
OPPIuM Technique and Myolysis With Diode Laser Dwls
|
N/A | |
Not yet recruiting |
NCT04191603 -
TWO DÄ°FFERENT ELECTROSURGERY DEVICES AS MONOPOLAR HOOC AND PLASMAKINETIC BIPOLAR SPATULA EFFECTIVENESS DURING COLPOTOMY
|
N/A | |
Terminated |
NCT04132349 -
Ulipristal Acetate in Symptomatic Uterine Fibroid
|
Phase 4 | |
Completed |
NCT03021720 -
Satisfaction of Patients With Trans-Arterial Radial Access: Quality of Life in Uterine Fibroid Embolization Trial
|
N/A | |
Recruiting |
NCT04209036 -
Can 3D Laparoscopy Improve Surgical Performances in Surgeons in Training?
|
||
Completed |
NCT05086770 -
Comparison of Pain After Uterine Artery Embolization Using Gelatin Microsphere or Tris-acryl Gelatin Microsphere
|
N/A | |
Recruiting |
NCT05416424 -
Life Study: Lifestyle Intervention in Fibroid Elimination
|
N/A | |
Not yet recruiting |
NCT05695690 -
Role of US in Uterine Fibroids in Comparison With MRI Using FIGO Classification
|
||
Completed |
NCT04832906 -
UA Versus UAE in Treatment of Fibroids
|
Phase 4 | |
Completed |
NCT03444987 -
The Role of Fibroblast Activation in Uterine Fibroid
|
||
Active, not recruiting |
NCT06244251 -
Comparison Between Laparoendoscopic Single-site Surgery and Multi-port Laparoscopy in Treating Uterine Fibroids
|
N/A | |
Not yet recruiting |
NCT03450421 -
Safety and Efficacy of Actamaxâ„¢Adhesion Barrier in Women Undergoing Laparoscopic Abdominopelvic Surgery/Myomectomy
|
N/A | |
Not yet recruiting |
NCT05840042 -
Epidemiology and Risk Factors of Uterine Fibroids in China
|
||
Completed |
NCT04345003 -
MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids
|
N/A | |
Recruiting |
NCT03118037 -
Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry
|
||
Completed |
NCT03103087 -
LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
|
Phase 3 | |
Completed |
NCT03211481 -
Design of an Intra-operative Blood Conservation Pathway at Open Myomectomy
|