Uterine Fibroids Clinical Trial
Official title:
An International Phase 3 Double-Blind, Placebo-Controlled, Randomized Withdrawal Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Verified date | April 2022 |
Source | Myovant Sciences GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objectives of this randomized withdrawal study are to evaluate the long-term efficacy and safety of the combination of relugolix, estradiol (E2) and norethindrone acetate (NETA), once daily, for up to 104 weeks in patients with uterine fibroids who have completed a total of 52 weeks of treatment, including a 24-week treatment period in a parent study (study MVT-601-3001 or MVT-601-3002) and a 28-week treatment period in the open-label extension study (MVT-601-3003), and who meet the definition of responder, defined as a patient who demonstrates a menstrual blood loss of < 80 mL and at least a 50% reduction from parent study baseline menstrual blood loss volume on the alkaline hematin analysis of the feminine products returned at Week 48 in the extension study.
Status | Completed |
Enrollment | 229 |
Est. completion date | November 18, 2021 |
Est. primary completion date | February 19, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 51 Years |
Eligibility | Inclusion Criteria: 1. Completed the open-label extension study (MVT-601-3003). 2. Is a responder: Has a menstrual blood loss of < 80 mL AND at least a 50% reduction from the parent study Baseline based on the results of the alkaline hematin testing performed on the feminine products returned at the Week 48 visit of the extension study. 3. Is not expected to undergo gynecological surgery or ablation procedures for uterine fibroids within the study period 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 or extension study. 2. Has a weight that exceeds the weight limit of the DXA scanner 3. Has developed any contraindication to treatment with estradiol or norethindrone acetate 4. Is currently pregnant or lactating, or intends to become pregnant during the study period 5. Met a withdrawal criterion in the OLE study. |
Country | Name | City | State |
---|---|---|---|
Brazil | Porto Alegre | Porto Alegre | |
Brazil | Porto Alegre | Porto Alegre | RIO Grande DO SUL |
Brazil | São Bernardo do Campo | São Bernardo Do Campo | SAO Paulo |
Brazil | Sao Paulo | São Paulo | Sao Paulo |
Brazil | São Paulo | São Paulo | |
Chile | Providencia | Providencia | |
Chile | San Ramon | San Ramón | |
Chile | Santiago | Santiago | |
Czechia | Ceské Budejovice | Ceské Budejovice | |
Czechia | Olomouc | Olomouc | |
Czechia | Pisek | Písek | |
Hungary | Debrecen | Debrecen | |
Hungary | Debrecen | Debrecen | |
Hungary | Gyula | Gyula | |
Hungary | Kecskemét | Kecskemét | Bacs-kiskun |
Hungary | Nyíregyháza | Nyíregyháza | |
Hungary | Szentes | Szentes | |
Italy | Catanzaro | Catanzaro | |
Italy | Roma | Roma | |
Italy | SIENA | Siena | |
Italy | Torino | Torino | |
Poland | Bialystok | Bialystok | |
Poland | Katowice | Katowice | |
Poland | Poznan | Poznan | |
Poland | Szczecin | Szczecin | Zachodniopomorskie |
Poland | Warszawa | Warszawa | |
South Africa | Bloemfontein | Bloemfontein | Free State |
South Africa | Cape Town | Cape Town | Western Cape |
South Africa | Cape Town | Cape Town | Western Cape |
South Africa | Centurion | Centurion | Gauteng |
South Africa | Durban | Durban | |
South Africa | Roodepoort | Roodepoort | |
United States | Atlanta | Atlanta | Georgia |
United States | Augusta | Augusta | Georgia |
United States | Aventura | Aventura | Florida |
United States | Baltimore | Baltimore | Maryland |
United States | Birmingham | Birmingham | Alabama |
United States | Bluffton | Bluffton | South Carolina |
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 | Clearwater | Clearwater | Florida |
United States | College Park | College Park | Georgia |
United States | Columbia | Columbia | South Carolina |
United States | Covington | Covington | Louisiana |
United States | Dallas | Dallas | Texas |
United States | Dacatur | 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 | Ft. Lauderdale | Fort Lauderdale | Florida |
United States | Fort Myers | Fort Myers | Florida |
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 | Lawrenceville | Lawrenceville | New Jersey |
United States | Longview | Longview | Texas |
United States | Los Angeles | Los Angeles | California |
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 | Miami | Miami | Florida |
United States | Miami | Miami | Florida |
United States | Miami | Miami | Florida |
United States | Norcross | Norcross | Georgia |
United States | Norfolk | Norfolk | Virginia |
United States | Norwalk | Norwalk | California |
United States | Oak brook | Oak Brook | Illinois |
United States | Orlando | Orlando | Florida |
United States | Oviedo | Oviedo | Florida |
United States | Raleigh | Raleigh | North Carolina |
United States | Raleigh | Raleigh | North Carolina |
United States | Richmond | Richmond | Virginia |
United States | San Antonio | San Antonio | Texas |
United States | San Antonio | San Antonio | Texas |
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 | Smyrna | Smyrna | Georgia |
United States | Spokane | Spokane | Washington |
United States | Tampa | Tampa | Florida |
United States | Towson | Towson | Maryland |
United States | Tucson | Tucson | Arizona |
United States | Webster | Webster | Texas |
United States | United States, Florida | West Palm Beach | Florida |
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, Brazil, Chile, Czechia, Hungary, Italy, Poland, South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of women who maintain a menstrual blood loss (MBL) volume of < 80 mL | MBL volume is measured using the alkaline hematin method. | at Week 24 (Week 72 relative to the parent study baseline) | |
Secondary | Proportion of women who maintain a MBL volume of < 80 mL | MBL volume is measured using the alkaline hematin method. | at Week 52 (Week 104 relative to the parent study baseline) | |
Secondary | Change in MBL volume | MBL volume is measured using the alkaline hematin method. | from Baseline up to Week 52 (Week 104 relative to the parent study baseline) | |
Secondary | Proportion of women who responded (MBL volume < 80 mL) to retreatment during retreatment period | MBL volume is measured using the alkaline hematin method. | at Week 52 (Week 104 relative to the parent study baseline) | |
Secondary | Proportion of women with heavy menstrual bleeding | Defined as the proportion of women with MBL volume of = 80 mL at any time. MBL volume is measured using the alkaline hematin method. | at Week 24 and 52 (Week 72 and Week 104 relative to the parent study baseline) | |
Secondary | Time to resumption of heavy menstrual bleeding | Defined as time to MBL volume of = 80 mL. MBL volume is measured using the alkaline hematin method. | up to Week 52 (Week 104 relative to the parent study baseline) | |
Secondary | Proportion of women with suppression of bleeding | Will be assessed using patient daily diary and MBL volume measured using the alkaline hematin method. | at Week 24 and 52 (Week 72 and Week 104 relative to the parent study baseline) | |
Secondary | Time to resumption of menses in women who are amenorrhoeic | Will be assessed using patient daily diary. | up to Week 52 (Week 104 relative to the parent study baseline) | |
Secondary | Change in hemoglobin concentration | Blood samples will be collected from participants for hemoglobin measurements. | from Baseline up to Week 52 (Week 104 relative to the parent study baseline) | |
Secondary | Change in impact on quality of life: UFS-QOL | Assessed using the Uterine Fibroid Symptom Health-Related Quality of Life Questionnaire (UFS-QOL) | from Baseline up to Week 52 (Week 104 relative to the parent study baseline) | |
Secondary | Change in Patient Global Assessment (PGA) for symptoms | The PGA for symptoms is a 1-item questionnaire designed to assess participants impression of the severity of their symptoms related to uterine fibroids. | from Baseline up to Week 52 (Week 104 relative to the parent study baseline) | |
Secondary | Change in PGA for function | The PGA for function is a 1-item questionnaire designed to assess participants impression of how their symptoms related to uterine fibroids affected their usual activities. | from Baseline up to Week 52 (Week 104 relative to the parent study baseline) | |
Secondary | Bone Mineral Density (BMD) | Assessed by dual-energy X-ray absorptiometry (DXA) scan. | from parent study Baseline up to Week 104 | |
Secondary | Percentage of participants with adverse events (AEs) as a measure of safety and tolerability | Assessed by percentage of participants with AEs and serious AEs. | up to 52 weeks | |
Secondary | Serum estradiol concentrations | Blood samples will be collected from participants for estradiol measurements. | up to 52 weeks |
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