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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03751124
Other study ID # MVT-601-035
Secondary ID 2018-001368-43
Status Completed
Phase Phase 3
First received
Last updated
Start date October 16, 2018
Est. completion date November 18, 2021

Study information

Verified date April 2022
Source Myovant Sciences GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

This randomized withdrawal study is an international phase 3 double-blind, placebo-controlled study that will enroll eligible patients with uterine fibroids who have completed the 24-week treatment period in a parent study (MVT-601-3001 or MVT-601-3002) and the 28-week treatment period of the open-label extension study (MVT-601-3003). When including treatment during the parent study and the extension study, patients completing this randomized withdrawal study will have received up to a total of 104 weeks of treatment with relugolix. Approximately 360 women with heavy menstrual bleeding associated with uterine fibroids completing the extension study with a response to treatment will be eligible to participate in this study. A responder is 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. Screening procedures will be done on the same day as the Week 52 visit for the extension study. This visit will be referred to as the "Week 52/Baseline visit." When the Week 52/Baseline procedures in the extension study have been completed, the investigator will assess patient eligibility for participation in this study. The eligibility assessment will be based on data available at the Week 52/Baseline visit. Patients will be asked to provide feminine products for alkaline hematin analysis at each visit until the analysis confirms the return of heavy menstrual bleeding. The patients will then be offered retreatment with open-label relugolix with E2/NETA with the onset of the next menses. They will resume collection of feminine products for alkaline hematin analysis until two consecutive analyses confirm resolution of heavy menstrual bleeding (menstrual blood loss of < 80 mL). Safety will be assessed throughout the study by monitoring adverse events, vital signs, physical examinations, clinical laboratory tests, and assessments of bone mineral density.


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
Relugolix
Relugolix 40 mg tablet administered orally once daily
Estradiol/norethindrone acetate
Capsule containing co-formulated tablet of estradiol 1.0 mg and norethindrone acetate 0.5 mg administered orally once daily
Placebo for relugolix
Placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor
Placebo for E2/NETA
Placebo capsule administered orally once daily and designed to match the E2/NETA capsule in size, shape, color, and odor

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Myovant Sciences GmbH

Countries where clinical trial is conducted

United States,  Brazil,  Chile,  Czechia,  Hungary,  Italy,  Poland,  South Africa, 

Outcome

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
See also
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