Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

May 31, 2024 updated by: Myovant Sciences GmbH

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
229

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Porto Alegre, Brazil, 90510-040
        • Porto Alegre
      • São Paulo, Brazil, 04266-010
        • São Paulo
    • RIO Grande DO SUL
      • Porto Alegre, RIO Grande DO SUL, Brazil, 90510-040
        • Porto Alegre
    • SAO Paulo
      • São Bernardo Do Campo, SAO Paulo, Brazil, 09715-090
        • São Bernardo do Campo
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 01317-000
        • São Paulo
  • Chile
      • Providencia, Chile, 7510186
        • Providencia
      • San Ramón, Chile, 8880465
        • San Ramon
      • Santiago, Chile, 8360160
        • Santiago
  • Czechia
      • Olomouc, Czechia, 772 00
        • Olomouc
      • Písek, Czechia, 39701
        • Pisek
      • České Budějovice, Czechia, 370 01
        • České Budějovice
  • Hungary
      • Debrecen, Hungary, 4025
        • Debrecen
      • Debrecen, Hungary, 4024
        • Debrecen
      • Gyula, Hungary, 5700
        • Gyula
      • Nyíregyháza, Hungary, 4400
        • Nyíregyháza
      • Szentes, Hungary, 6600
        • Szentes
    • Bacs-kiskun
      • Kecskemét, Bacs-kiskun, Hungary, 6000
        • Kecskemét
  • Italy
      • Catanzaro, Italy, 88100
        • Catanzaro
      • Roma, Italy, 00168
        • Roma
      • Siena, Italy, 53100
        • Siena
      • Torino, Italy, 10126
        • Torino
  • Poland
      • Białystok, Poland, 15-464
        • Bialystok
      • Katowice, Poland, 40-123
        • Katowice
      • Poznan, Poland, 60-192
        • Poznan
      • Warszawa, Poland, 02-201
        • Warszawa
    • Zachodniopomorskie
      • Szczecin, Zachodniopomorskie, Poland, 71-270
        • Szczecin
  • South Africa
      • Durban, South Africa, 4126
        • Durban
      • Roodepoort, South Africa, 1724
        • Roodepoort
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Bloemfontein
    • Gauteng
      • Centurion, Gauteng, South Africa, 0157
        • Centurion
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7405
        • Cape Town
      • Cape Town, Western Cape, South Africa, 7500
        • Cape Town
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Birmingham
    • Arizona
      • Mesa, Arizona, United States, 85209
        • Mesa
      • Tucson, Arizona, United States, 85712
        • Tucson
    • California
      • Canoga Park, California, United States, 91303
        • Canoga Park
      • Huntington Beach, California, United States, 92647
        • Huntington Beach
      • La Mesa, California, United States, 91942
        • La Mesa
      • Los Angeles, California, United States, 90057
        • Los Angeles
      • Norwalk, California, United States, 90650
        • Norwalk
      • San Diego, California, United States, 92111
        • San Diego
    • Colorado
      • Denver, Colorado, United States, 80209
        • Denver
      • Lakewood, Colorado, United States, 80228
        • Lakewood
    • Florida
      • Aventura, Florida, United States, 33180
        • Aventura
      • Clearwater, Florida, United States, 33759
        • Clearwater
      • DeLand, Florida, United States, 32720
        • Deland
      • Fort Lauderdale, Florida, United States, 33316
        • Ft. Lauderdale
      • Fort Myers, Florida, United States, 33912
        • Fort Myers
      • Jacksonville, Florida, United States, 32207
        • Jacksonville
      • Jupiter, Florida, United States, 33458
        • Jupiter
      • Margate, Florida, United States, 33063
        • Margate
      • Miami, Florida, United States, 33126
        • Miami
      • Miami, Florida, United States, 33155
        • Miami
      • Miami, Florida, United States, 33165
        • Miami
      • Orlando, Florida, United States, 33759
        • Orlando
      • Oviedo, Florida, United States, 32765
        • Oviedo
      • Sarasota, Florida, United States, 34239
        • Sarasota
      • Tampa, Florida, United States, 33613
        • Tampa
      • West Palm Beach, Florida, United States, 33409
        • West Palm Beach
      • West Palm Beach, Florida, United States, 33409
        • United States, Florida
      • Weston, Florida, United States, 33327
        • Weston
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta
      • Augusta, Georgia, United States, 30912
        • Augusta
      • College Park, Georgia, United States, 30349
        • College Park
      • Decatur, Georgia, United States, 30034
        • Dacatur
      • Duluth, Georgia, United States, 30097
        • Duluth
      • Norcross, Georgia, United States, 30093
        • Norcross
      • Savannah, Georgia, United States, 31406
        • Savannah
      • Smyrna, Georgia, United States, 30080
        • Smyrna
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Chicago
      • Oak Brook, Illinois, United States, 60523
        • Oak brook
    • Kansas
      • Shawnee Mission, Kansas, United States, 66218
        • Shawnee
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Covington
      • Marrero, Louisiana, United States, 70072
        • Marrero
      • Metairie, Louisiana, United States, 70006
        • Metairie
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • Baltimore
      • Towson, Maryland, United States, 21204
        • Towson
    • Michigan
      • Canton, Michigan, United States, 48187
        • Canton
      • Detroit, Michigan, United States, 48201
        • Detroit
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Las Vegas
      • Las Vegas, Nevada, United States, 89109
        • Las Vegas
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Lawrenceville
    • New York
      • Williamsville, New York, United States, 14221
        • Williamsville
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • Durham
      • Raleigh, North Carolina, United States, 27612
        • Raleigh
      • Raleigh, North Carolina, United States, 27607
        • Raleigh
      • Winston-Salem, North Carolina, United States, 27103
        • Winston Salem
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Cincinnati
    • South Carolina
      • Bluffton, South Carolina, United States, 29910
        • Bluffton
      • Charleston, South Carolina, United States, 29406
        • Charleston
      • Columbia, South Carolina, United States, 29201
        • Columbia
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga
      • Memphis, Tennessee, United States, 38120
        • Memphis
      • Memphis, Tennessee, United States, 38119
        • Memphis
    • Texas
      • Dallas, Texas, United States, 75231
        • Dallas
      • Houston, Texas, United States, 77030
        • Houston
      • Houston, Texas, United States, 77054
        • Houston
      • Longview, Texas, United States, 75605
        • Longview
      • San Antonio, Texas, United States, 78229
        • San Antonio
      • San Antonio, Texas, United States, 78258
        • San Antonio
      • Webster, Texas, United States, 77598
        • Webster
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Norfolk
      • Richmond, Virginia, United States, 23225
        • Richmond
    • Washington
      • Spokane, Washington, United States, 99207
        • Spokane

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Description

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 dual-energy x-ray absorptiometry (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 open-label extension (OLE) study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Relugolix plus E2/NETA
Relugolix 40 mg co-administered with estradiol (1.0 mg) and norethindrone acetate (0.5 mg) for up to 52 weeks.
Drug: Relugolix
Relugolix 40 mg tablet administered orally once daily
Other Names:
  • TAK-385
Drug: Estradiol/norethindrone acetate
Capsule containing co-formulated tablet of estradiol 1.0 mg and norethindrone acetate 0.5 mg administered orally once daily
Other Names:
  • E2/NETA
  • Low-dose hormonal add-back
Placebo Comparator: Placebo tablets and capsules
  • Placebo for relugolix co-administered with placebo for E2/NETA for up to 52 weeks or until heavy menstrual bleeding returns.
  • Retreatment with open-label relugolix with E2/NETA will be offered if heavy menstrual bleeding returns.
Drug: Placebo for relugolix
Placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor
Drug: Placebo for E2/NETA
Placebo capsule administered orally once daily and designed to match the E2/NETA capsule in size, shape, color, and odor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage Of Participants Who Maintained MBL Volume Of <80 Milliliters (mL) At Week 76 During The Randomized Treatment Period
Time Frame: Week 52/Baseline up to Week 76
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding. The sustained responder rate was calculated as the Kaplan-Meier estimate of the cumulative probability of MBL volume < 80 mL through Week 76 using the Kaplan-Meier method.
Week 52/Baseline up to Week 76

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time To MBL Volume ≥80 mL During The Randomized Treatment Period
Time Frame: From Week 52/Baseline through Week 104
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
From Week 52/Baseline through Week 104
Percentage Of Participants Who Maintained MBL Volume Of <80 mL At Week 104 During The Randomized Treatment Period
Time Frame: Week 52/Baseline up to Week 104
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding. The sustained responder rate was calculated as the Kaplan-Meier estimate of the cumulative probability of MBL volume < 80 mL through Week 104 using the Kaplan-Meier method.
Week 52/Baseline up to Week 104
Percentage Of Participants Achieving Or Maintaining Amenorrhea At Week 76 During The Randomized Treatment Period
Time Frame: Week 76
Assessed using participant daily diary and MBL volume measured using the alkaline hematin method. Participants were deemed to be amenorrhoeic if one of the following criteria was met: No feminine products returned due to reported amenorrhea, or No feminine products returned due to reported spotting or feminine product collection with a negligible observed MBL volume (<5 mL) coupled with other data indicating infrequent non-cyclic bleeding/spotting. If no feminine product collection because participant failed to collect used products per protocol or due to "Other" reason, the amenorrhea status was set to missing. Missing responses for menstrual bleeding questions in the paper diary were treated as "No Bleeding" if paper diary entry/compliance rate was >70%.
Week 76
Change From Week 52/Baseline To Week 76 In MBL Volume During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 76
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. Participants with amenorrhea are assigned with an MBL value of 0 mL and participants with spotting are assigned with an MBL value of 4.99 mL. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
Week 52/Baseline to Week 76
Change From Week 52/Baseline To Week 104 In MBL Volume During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 104
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. Participants with amenorrhea are assigned with an MBL value of 0 mL and participants with spotting are assigned with an MBL value of 4.99 mL. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
Week 52/Baseline to Week 104
Percentage Change From Week 52/Baseline To Week 76 In MBL Volume During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 76
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. Participants with amenorrhea are assigned with an MBL value of 0 mL and participants with spotting are assigned with an MBL value of 4.99 mL. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
Week 52/Baseline to Week 76
Percentage Change From Week 52/Baseline To Week 104 In MBL Volume During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 104
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. Participants with amenorrhea are assigned with an MBL value of 0 mL and participants with spotting are assigned with an MBL value of 4.99 mL. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
Week 52/Baseline to Week 104
Percentage Of Participants Achieving Or Maintaining Amenorrhea At Week 104 During The Randomized Treatment Period
Time Frame: Week 104
Assessed using participant daily diary and MBL volume measured using the alkaline hematin method. Participants were deemed to be amenorrhoeic if one of the following criteria was met: No feminine products returned due to reported amenorrhea or no feminine products returned due to reported spotting or feminine product collection with a negligible observed MBL volume (<5 mL) coupled with other data indicating infrequent non-cyclic bleeding/spotting. If no feminine product collection because participant failed to collect used products per protocol or due to "Other" reason, the amenorrhea status was set to missing. Missing responses for menstrual bleeding questions in the paper diary were treated as "No Bleeding" if paper diary entry/compliance rate was >70%.
Week 104
Percentage Of Participants Who Responded (MBL Volume <80 mL) To Retreatment During The Retreatment Period
Time Frame: From Initiation of Retreatment to Week 104
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
From Initiation of Retreatment to Week 104
Percentage Of Participants Whose Menses Had Resumed During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 76 and Week 104
Participants who were previously amenorrhoeic were deemed to resume menses according to the following rules: MBL volume of collected feminine product was ≥5 mL; MBL volume of collected feminine product was <5 mL; however, there were more than 5 days and more than 3 consecutive days of bleeding with feminine product use during the visit; no feminine products were returned because the participant failed to collect used products per protocol; however, there were more than 5 days and more than 3 consecutive days of bleeding with feminine product use during the visit; or no feminine products were returned due to other reasons that indicated menstruation had occurred; also, there were more than 5 days and more than 3 consecutive days of bleeding with feminine product use during the visit.
Week 52/Baseline to Week 76 and Week 104
Time To Resumption Of Menses For Participants Who Were Amenorrhoeic At Week 52/Baseline During The Randomized Treatment Period
Time Frame: Week 52/Baseline up to Week 104
Assessed using participant daily diary. Participants were deemed to be amenorrhoeic if one of the following criteria was met: No feminine products returned due to reported amenorrhea, or No feminine products returned due to reported spotting or feminine product collection with a negligible observed MBL volume (<5 mL) coupled with other data indicating infrequent non-cyclic bleeding/spotting. If no feminine product collection because participant failed to collect used products per protocol or due to "Other" reason, the amenorrhea status was set to missing. Missing responses for menstrual bleeding questions in the paper diary were treated as "No Bleeding" if paper diary entry/compliance rate was >70%.
Week 52/Baseline up to Week 104
Change From Week 52/Baseline In Hemoglobin Concentration During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 76
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
Week 52/Baseline to Week 76
Change From Week 52/Baseline In Hemoglobin Concentration During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 104
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
Week 52/Baseline to Week 104
Percentage Of Participants With MBL Volume Of ≥80 mL At Week 76 And Week 104 During the Randomized Treatment Period
Time Frame: From Week 52/Baseline to Week 76 and Week 104
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
From Week 52/Baseline to Week 76 and Week 104
Percent Change From Week 52/Baseline In Hemoglobin Concentration During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 64
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
Week 52/Baseline to Week 64
Percent Change From Week 52/Baseline In Hemoglobin Concentration During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 76
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
Week 52/Baseline to Week 76
Percent Change From Week 52/Baseline In Hemoglobin Concentration During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 104
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
Week 52/Baseline to Week 104
Percentage Of Participants Who Had Hemoglobin Level ≤10.5 g/dL Over Time During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 76
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
Week 52/Baseline to Week 76
Percentage Of Participants Who Had Hemoglobin Level ≤10.5 g/dL Over Time During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 104
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
Week 52/Baseline to Week 104
Percentage Of Participants Who Had Hemoglobin Level <11.6 g/dL Over Time During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 76
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
Week 52/Baseline to Week 76
Percentage Of Participants Who Had Hemoglobin Level <11.6 g/dL Over Time During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 104
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
Week 52/Baseline to Week 104
Change From Week 52/Baseline In Short Form 36v2 (SF-36v2) Domain During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 76
The Short-Form Health Survey Standard (SF-36) is a validated, 36-item questionnaire, assessing general overall quality of life and was completed by participants on paper before other study procedures were performed, except for at the Week 52/Baseline visit, which was completed after eligibility for this study was confirmed and all Week 52 procedures for the long-term extension study were completed. Scores are calculated for each domain and 2 summary scores - a physical component summary score (Domains [number of items]: Physical Functioning [10], Role-Physical [4], Bodily Pain [2], General Health [5]), a mental component summary score (Domains [number of items]: Vitality [4], Social Functioning [2], Role-Emotional [3], and Mental Health [5]), and reported Health Transition [1]. Individual domain and component summary scores range from 0 to 100. Higher scores indicate higher health-related quality of life.
Week 52/Baseline to Week 76
Change From Week 52/Baseline In Short Form 36v2 (SF-36v2) Domain During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 104
The Short-Form Health Survey Standard (SF-36) is a validated, 36-item questionnaire, assessing general overall quality of life and was completed by participants on paper before other study procedures were performed, except for at the Week 52/Baseline visit, which was completed after eligibility for this study was confirmed and all Week 52 procedures for the long-term extension study were completed. Scores are calculated for each domain and 2 summary scores - a physical component summary score (Domains [number of items]: Physical Functioning [10], Role-Physical [4], Bodily Pain [2], General Health [5]), a mental component summary score (Domains [number of items]: Vitality [4], Social Functioning [2], Role-Emotional [3], and Mental Health [5]), and reported Health Transition [1]. Individual domain and component summary scores range from 0 to 100. Higher scores indicate higher health-related quality of life.
Week 52/Baseline to Week 104
Change From Week 52/Baseline In SF-36v2 Summary Component Scores During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 76
The Short-Form Health Survey Standard (SF-36) is a validated, 36-item questionnaire, assessing general overall quality of life and was completed by participants on paper before other study procedures were performed, except for at the Week 52/Baseline visit, which was completed after eligibility for this study was confirmed and all Week 52 procedures for the long-term extension study were completed. Scores are calculated for each domain and 2 summary scores - a physical component summary (PCS) score (Domains [number of items]: Physical Functioning [10], Role-Physical [4], Bodily Pain [2], General Health [5]), a mental component summary (MCS) score (Domains [number of items]: Vitality [4], Social Functioning [2], Role-Emotional [3], and Mental Health [5]), and reported Health Transition [1]. Individual domain and component summary scores range from 0 to 100. Higher scores indicate higher health-related quality of life.
Week 52/Baseline to Week 76
Change From Week 52/Baseline In SF-36v2 Summary Component Scores During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 104
The Short-Form Health Survey Standard (SF-36) is a validated, 36-item questionnaire, assessing general overall quality of life and was completed by participants on paper before other study procedures were performed, except for at the Week 52/Baseline visit, which was completed after eligibility for this study was confirmed and all Week 52 procedures for the long-term extension study were completed. Scores are calculated for each domain and 2 summary scores - a physical component summary (PCS) score (Domains [number of items]: Physical Functioning [10], Role-Physical [4], Bodily Pain [2], General Health [5]), a mental component summary (MCS) score (Domains [number of items]: Vitality [4], Social Functioning [2], Role-Emotional [3], and Mental Health [5]), and reported Health Transition [1]. Individual domain and component summary scores range from 0 to 100. Higher scores indicate higher health-related quality of life.
Week 52/Baseline to Week 104
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Function During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 76
The PGA for function is a 1-item questionnaire designed to assess participant's impression of the impact on their function related to uterine fibroids affected their usual activities and was completed on paper. The PGA for function was evaluated using a 5-point Likert scale (1 = No limitation at all; 5 = Extreme limitation) with higher numbers representing worse results. Endpoint values represent the worsening of function (deterioration), improvement of function (improvement), or no change by category at each time point. For example, a 4-category deterioration represents a change from 1 (No limitation at all) to 5 (Extreme limitation) and a 4-category improvement represents a change from 5 (Extreme limitation) to 1 (No limitation at all).
Week 52/Baseline to Week 76
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Function During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 104
The PGA for function is a 1-item questionnaire designed to assess participant's impression of the impact on their function related to uterine fibroids affected their usual activities and was completed on paper. The PGA for function was evaluated using a 5-point Likert scale (1 = No limitation at all; 5 = Extreme limitation) with higher numbers representing worse results. Endpoint values represent the worsening of function (deterioration), improvement of function (improvement), or no change by category at each time point. For example, a 4-category deterioration represents a change from 1 (No limitation at all) to 5 (Extreme limitation) and a 4-category improvement represents a change from 5 (Extreme limitation) to 1 (No limitation at all).
Week 52/Baseline to Week 104
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Symptoms During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 76
The PGA for symptoms is a 1-item questionnaire designed to assess participant's impression of the severity of their symptoms related to uterine fibroids and was completed on paper. The PGA for symptoms was evaluated using a 5-point Likert scale (1 = Not severe; 5 = Extremely severe) with higher numbers representing worse results. Endpoint values represent the worsening of symptoms (deterioration), improvement of symptoms (improvement), or no change by category at each time point. For example, a 4-category deterioration represents a change from 1 (Not severe) to 5 (Extremely severe) and a 4-category improvement represents a change from 5 (Extremely severe) to 1 (Not severe).
Week 52/Baseline to Week 76
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Symptoms During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 104
The PGA for symptoms is a 1-item questionnaire designed to assess participant's impression of the severity of their symptoms related to uterine fibroids and was completed on paper. The PGA for symptoms was evaluated using a 5-point Likert scale (1 = Not severe; 5 = Extremely severe) with higher numbers representing worse results. Endpoint values represent the worsening of symptoms (deterioration), improvement of symptoms (improvement), or no change by category at each time point. For example, a 4-category deterioration represents a change from 1 (Not severe) to 5 (Extremely severe) and a 4-category improvement represents a change from 5 (Extremely severe) to 1 (Not severe).
Week 52/Baseline to Week 104
Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Work Time Missed Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period
Time Frame: Week 52/Baseline up to Week 76

The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions.

Percent work time missed due to uterine fibroids was calculated from hours missed due to uterine fibroids divided by the sum of hours missed due to uterine fibroids plus hours actually worked. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
Week 52/Baseline up to Week 76
Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Work Time Missed Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period
Time Frame: Week 52/Baseline up to Week 104

The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions.

Percent work time missed due to uterine fibroids was calculated from hours missed due to uterine fibroids divided by the sum of hours missed due to uterine fibroids plus hours actually worked. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
Week 52/Baseline up to Week 104
Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Impairment While Working Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period
Time Frame: Week 52/Baseline up to Week 76

The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions.

Percent impairment while working due to uterine fibroid symptoms was calculated by taking the reported value from 1 (no effect) to 10 (completely prevented work) and dividing by 10. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
Week 52/Baseline up to Week 76
Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Impairment While Working Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period
Time Frame: Week 52/Baseline up to Week 104

The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions.

Percent impairment while working due to uterine fibroid symptoms was calculated by taking the reported value from 1 (no effect) to 10 (completely prevented work) and dividing by 10. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
Week 52/Baseline up to Week 104
Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Overall Work Impairment Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period
Time Frame: Week 52/Baseline up to Week 76

The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions.

Percent overall work impairment due to uterine fibroid symptoms was calculated from the work time missed due to uterine fibroids plus the value calculated from 1 minus the work time missed value multiplied by the value for impairment while working due to uterine fibroids. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
Week 52/Baseline up to Week 76
Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Overall Work Impairment Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period
Time Frame: Week 52/Baseline up to Week 104

The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions.

Percent overall work impairment due to uterine fibroid symptoms was calculated from the work time missed due to uterine fibroids plus the value calculated from 1 minus the work time missed value multiplied by the value for impairment while working due to uterine fibroids. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
Week 52/Baseline up to Week 104
Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Activity Impairment Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period
Time Frame: Week 52/Baseline up to Week 76

The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions.

Percent activity impairment due to uterine fibroid symptoms was calculated by taking the reported value from 1 (no effect) to 10 (completely prevented activity) and dividing by 10. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
Week 52/Baseline up to Week 76
Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Activity Impairment Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period
Time Frame: Week 52/Baseline up to Week 104

The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions.

Percent activity impairment due to uterine fibroid symptoms was calculated by taking the reported value from 1 (no effect) to 10 (completely prevented work) and dividing by 10. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages (0 to 100%), with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
Week 52/Baseline up to Week 104
Change From Week 52/Baseline In The UFS-QoL Bleeding And Pelvic Discomfort Score During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 76
Assessed using the UFS-QOL which is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. The UFS-QoL was completed on a paper questionnaire and participants were to answer the following questions: heavy bleeding during your menstrual period (Question 1), passing blood clots during your menstrual period (Question 2), and feeling tightness or pressure in your pelvic area (Question 5). Items are scored on a 5-point scale, ranging from "not at all" to "a very great deal." A summed score was created for questions 1, 2, and 5 and transformed to a normalized score with a range of possible values from 0 to 100, where a higher score was indicative of greater distress and a lower score of less distress (high scores = bad).
Week 52/Baseline to Week 76
Change From Week 52/Baseline In The UFS-QoL Bleeding And Pelvic Discomfort Score During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 104
Assessed using the UFS-QOL which is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. The UFS-QoL was completed on a paper questionnaire and participants were to answer the following questions: heavy bleeding during your menstrual period (Question 1), passing blood clots during your menstrual period (Question 2), and feeling tightness or pressure in your pelvic area (Question 5). Items are scored on a 5-point scale, ranging from "not at all" to "a very great deal." A summed score was created for questions 1, 2, and 5 and transformed to a normalized score with a range of possible values from 0 to 100, where a higher score was indicative of greater distress and a lower score of less distress (high scores = bad).
Week 52/Baseline to Week 104
Original: Change From Week 52/Baseline In The UFS-QoL Symptom Severity Score During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 76
Assessed using the UFS-QOL, which is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. The UFS-QoL was completed on a paper questionnaire and participants were to answer these questions. Items are scored on a 5-point scale, ranging from "not at all" to "a very great deal." A summed score was created for questions 1 through 8 and transformed to a normalized score with a range of possible values from 0 to 100, where a higher score was indicative of greater symptom severity and a lower score of lower symptom severity (negative score = improvement).
Week 52/Baseline to Week 76
New: Change From Week 52/Baseline In The UFS-QoL Symptom Severity Score During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 104
Assessed using the UFS-QOL, which is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. The UFS-QoL was completed on a paper questionnaire and participants were to answer these questions. Items are scored on a 5-point scale, ranging from "not at all" to "a very great deal." A summed score was created for questions 1 through 8 and transformed to a normalized score with a range of possible values from 0 to 100, where a higher score was indicative of greater symptom severity and a lower score of lower symptom severity (negative score = improvement).
Week 52/Baseline to Week 104
Change From Week 52/Baseline In The UFS-QoL Score by Health-Related Quality Of Life Subscale And Total Scores During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 76
Assessed using the UFS-QOL which, is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. Items are scored on a 5-point scale, ranging from "none of the time" to "all of the time." The UFS-QoL was completed on a paper questionnaire and participants were to answer these questions. Questions 9 through 37 were used to calculate the total scores and the following subscales: concern, activities, revised activities, energy/mood, control, self-conscious, and sexual function. All raw scores are transformed to normalized scores with a range of possible values from 0 to 100. A positive score indicates improvement.
Week 52/Baseline to Week 76
Change From Week 52/Baseline In The UFS-QoL Score by Health-Related Quality Of Life Subscale And Total Scores During The Randomized Treatment Period
Time Frame: Week 52/Baseline to Week 104
Assessed using the UFS-QOL which, is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. Items are scored on a 5-point scale, ranging from "none of the time" to "all of the time." The UFS-QoL was completed on a paper questionnaire and participants were to answer these questions. Questions 9 through 37 were used to calculate the total scores and the following subscales: concern, activities, revised activities, energy/mood, control, self-conscious, and sexual function. All raw scores are transformed to normalized scores with a range of possible values from 0 to 100. A positive score indicates improvement.
Week 52/Baseline to Week 104
Predose Concentration Of Estradiol At Week 56
Time Frame: Week 52/Baseline and Week 56
Blood samples were collected from participants for estradiol measurements and were analyzed using a standard clinical methodology. The change from Week 52/Baseline in estradiol concentration at Week 56 was presented in this outcome.
Week 52/Baseline and Week 56
Participants With Adverse Events (AEs) As A Measure Of Safety And Tolerability
Time Frame: Week 52/Baseline up to Week 104
Assessed by percentage of participants with AEs and serious AEs (SAEs). An AE was defined as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or a congenital anomaly/birth defect. Events of heavy menstrual bleeding were only reported if the event met criteria as an SAE. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Week 52/Baseline up to Week 104
Percent Change From Week 52/Baseline In BMD At Lumbar Spine (L1-L4)
Time Frame: Week 52/Baseline to Week 104
Assessed by dual-energy X-ray absorptiometry scan at the lumbar spine (L1-L4), total hip [presented separately], and femoral neck (same leg within each participant) [presented separately] at each designated timepoints. The least squares means and their 95% CI were based on analysis of covariance model with treatment, stratification factors, race as fixed factors, and age at Week 52/Baseline, Week 52/Baseline BMD value, and body mass index at Week 52/Baseline as covariates.
Week 52/Baseline to Week 104
Percent Change From Week 52/Baseline In BMD At Femoral Neck And Total Hip
Time Frame: Week 52/Baseline to Week 104
Assessed by dual-energy X-ray absorptiometry scan at the lumbar spine (L1-L4) [presented separately], total hip, and femoral neck (same leg within each participant) at each designated timepoints. The least squares means and their 95% CI were based on analysis of covariance model with treatment, stratification factors, race as fixed factors, and age at Week 52/Baseline, Week 52/Baseline BMD value, and body mass index at Week 52/Baseline as covariates.
Week 52/Baseline to Week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Myovant Sciences GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 16, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 19, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MVT-601-035
  • 2018-001368-43 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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