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Heavy Menstrual BleedingPhase 3NCT03412890

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

A Phase 3 study testing Relugolix and Estradiol/norethindrone acetate in people with Heavy Menstrual Bleeding and Uterine Fibroid, run by Myovant Sciences GmbH at 150 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study was to determine the long-term efficacy and safety of relugolix 40 milligrams (mg) once daily co-administered with 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… Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Heavy Menstrual Bleeding, Uterine Fibroid
What is being tested?
Relugolix and Estradiol/norethindrone acetate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
477 participants
Where
150 sitesin 9 countries
Study dates
19 Oct 2017to 13 Jan 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 1. Completed 24 weeks of study drug treatment and study participation in either pivotal study, MVT-601-3001 or MVT-601-3002

Who cannot join

  • 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 pivotal study (MVT-601-3001 or MVT-601-3002)
  • Met a withdrawal criterion in the pivotal study (MVT-601-3001 or MVT-601-3002).

Trial locations and contacts

150 sites in 9 countries.

150 sites in 9 countries

United States104 sites

  • Albuquerque

    Albuquerque, New Mexico, 87102

  • Andalusia

    Andalusia, Alabama, 36420

  • Atlanta

    Atlanta, Georgia, 30342

  • Atlanta

    Atlanta, Georgia, 30363

  • Augusta

    Augusta, Georgia, 30904

  • Aventura

    Aventura, Florida, 33180

  • Baltimore

    Baltimore, Maryland, 21208

  • Beaumont

    Beaumont, Texas, 77702

  • Birmingham

    Birmingham, Alabama, 35205

  • Bluffton

    Bluffton, South Carolina, 29910

  • Brooklyn

    Brooklyn, New York, 11201

  • Canoga Park

    Canoga Park, California, 91303

  • Canton

    Canton, Michigan, 48187

  • Charleston

    Charleston, South Carolina, 29406

  • Chattanooga

    Chattanooga, Tennessee, 37404

  • Chicago

    Chicago, Illinois, 60611

  • Cincinnati

    Cincinnati, Ohio, 45212

  • Cincinnati

    Cincinnati, Ohio, 45219

  • Clearwater

    Clearwater, Florida, 33759

  • College Park

    College Park, Georgia, 30349

  • Columbia

    Columbia, South Carolina, 29201

  • Columbus

    Columbus, Ohio, 43231

  • Covington

    Covington, Louisiana, 70433

  • Dallas

    Dallas, Texas, 75231

  • Decatur

    Decatur, Georgia, 30034

  • DeLand

    DeLand, Florida, 32720

  • Denver

    Denver, Colorado, 80209

  • Detroit

    Detroit, Michigan, 48201

  • Duluth

    Duluth, Georgia, 30097

  • Durham

    Durham, North Carolina, 27713

  • Englewood

    Englewood, Ohio, 45322

  • Ft. Lauderdale

    Fort Lauderdale, Florida, 33316

  • Fort Myers

    Fort Myers, Florida, 33912

  • Fort Worth

    Fort Worth, Texas, 76104

  • Hialeah

    Hialeah, Florida, 33016

  • Houston

    Houston, Texas, 77030

  • Houston

    Houston, Texas, 77054

  • Houston

    Houston, Texas, 77074

  • Huntington Beach

    Huntington Beach, California, 92647

  • Jacksonville

    Jacksonville, Florida, 32207

  • Jupiter

    Jupiter, Florida, 33458

  • La Mesa

    La Mesa, California, 91942

  • Lakewood

    Lakewood, Colorado, 80228

  • Las Vegas

    Las Vegas, Nevada, 89109

  • Las Vegas

    Las Vegas, Nevada, 89113

  • Las Vegas

    Las Vegas, Nevada, 89128

  • Lawrenceville

    Lawrenceville, New Jersey, 08648

  • Lincoln

    Lincoln, Nebraska, 68510

  • Little Rock

    Little Rock, Arkansas, 72204

  • Long Beach

    Long Beach, California, 90806

  • Longview

    Longview, Texas, 75605

  • Los Angeles

    Los Angeles, California, 90036

  • Los Angeles

    Los Angeles, California, 90057

  • Loxahatchee

    Loxahatchee Groves, Florida, 33470

  • Margate

    Margate, Florida, 33063

  • Marrero

    Marrero, Louisiana, 70072

  • Memphis

    Memphis, Tennessee, 38119

  • Memphis

    Memphis, Tennessee, 38120

  • Mesa

    Mesa, Arizona, 85209

  • Metairie

    Metairie, Louisiana, 70001

  • Metairie

    Metairie, Louisiana, 70006

  • Miami

    Miami, Florida, 33126

  • Miami

    Miami, Florida, 33155

  • Miami

    Miami, Florida, 33165

  • Mobile

    Mobile, Alabama, 36608

  • Naperville

    Naperville, Illinois, 60540

  • New Port Richey

    New Port Richey, Florida, 34652

  • New York

    New York, New York, 10022

  • Norcross

    Norcross, Georgia, 30093

  • Norfolk

    Norfolk, Virginia, 23502

  • Norfolk

    Norfolk, Virginia, 23507

  • Norwalk

    Norwalk, California, 90650

  • Oakbrook

    Oakbrook Terrace, Illinois, 60523

  • Orlando

    Orlando, Florida, 32808

  • Oviedo

    Oviedo, Florida, 32765

  • Palm Harbor

    Palm Harbor, Florida, 34684

  • Panorama

    Panorama City, California, 91402

  • Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Raleigh

    Raleigh, North Carolina, 27607

  • Raleigh

    Raleigh, North Carolina, 27612

  • Richmond

    Richmond, Virginia, 23225

  • Saginaw

    Saginaw, Michigan, 48604

  • Saint Cloud

    Saint Cloud, Florida, 34769

  • Salt Lake City

    Salt Lake City, Utah, 84107

  • Salt Lake City

    Salt Lake City, Utah, 84124

  • San Antonio

    San Antonio, Texas, 78229

  • San Antonio

    San Antonio, Texas, 78258

  • San Diego

    San Diego, California, 92108

  • San Diego

    San Diego, California, 92111

  • Sarasota

    Sarasota, Florida, 34239

  • Savannah

    Savannah, Georgia, 31406

  • Shawnee

    Shawnee Mission, Kansas, 66218

  • Spokane

    Spokane, Washington, 99207

  • Sugar Land

    Sugar Land, Texas, 77479

  • Tampa

    Tampa, Florida, 33606

  • Tampa

    Tampa, Florida, 33613

  • Towson

    Towson, Maryland, 21204

  • Tucson

    Tucson, Arizona, 85712

  • Washington

    Washington D.C., District of Columbia, 20036

  • Webster

    Webster, Texas, 77598

  • West Palm Beach

    West Palm Beach, Florida, 33409

  • Weston

    Weston, Florida, 33327

  • Williamsville

    Williamsville, New York, 14221

  • Winston-Salem

    Winston-Salem, North Carolina, 27103

Other trials in United States

Brazil8 sites

  • Botucatu

    Botucatu, 18618-686

  • Porto Alegre

    Porto Alegre, 90035-903

  • Porto Alegre

    Porto Alegre, 90510-040

  • Santo Andre

    Santo André, Santo Andre, 09190-510

  • Santo André

    Santo André, São Paulo, 09190-510

  • São Bernardo Do Campo

    São Bernardo do Campo, São Paulo, 09715-090

  • Sao Paulo

    São Paulo, São Paulo, 01317-000

  • Sao Paulo

    São Paulo, São Paulo, 04266-010

Other trials in Brazil

Poland8 sites

  • Bialystok

    Bialystok, 15-464

  • Katowice

    Katowice, Silesian Voivodeship, 40-123

  • Lódz

    Lódz, Łódź Voivodeship, 90-602

  • Lublin

    Lublin, Lublin Voivodeship, 20-632

  • Poznan

    Poznan, Greater Poland Voivodeship, 60-192

  • Skórzewo

    Skórzewo, Greater Poland Voivodeship, 60-185

  • Szczecin

    Szczecin, West Pomeranian Voivodeship, 71-270

  • Warszawa

    Warsaw, Masovian Voivodeship, 02-201

Other trials in Poland

South Africa7 sites

  • Bloemfontein

    Bloemfontein, 9301

  • Cape Town

    Cape Town, 7405

  • Cape Town

    Cape Town, 7500

  • Centurion

    Centurion, Gauteng, 0157

  • Durban

    Durban, KwaZulu-Natal, 4001

  • Port Elizabeth

    Port Elizabeth, 6001

  • Roodepoort

    Roodepoort, Gauteng, 1724

Other trials in South Africa

Hungary6 sites

  • Debrecen

    Debrecen, Hajdú-Bihar, 4024

  • Debrecen

    Debrecen, 4025

  • Gyula

    Gyula, Bekes County, 5700

  • Kecskemét

    Kecskemét, Bács-Kiskun county, 6000

  • Nyíregyháza

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

  • Szentes

    Szentes, 6600

Other trials in Hungary

Italy5 sites

  • Catanzaro

    Catanzaro, 88100

  • Firenze

    Florence, 50134

  • Roma

    Roma, 00168

  • Siena

    Siena, 53100

  • Torino

    Torino, 10126

Other trials in Italy

Belgium4 sites

  • Brussels

    Brussels, 1200

  • Gent

    Ghent, Oost-vlaanderen, 9000

  • Jette

    Jette, 1090

  • La Louvière

    La Louvière, Hainaut, 7100

Other trials in Belgium

Chile4 sites

  • Providencia

    Providencia, 7510186

  • San Ramon

    San Ramón, 8880465

  • Region Metropolitana

    Santiago, 8320165

  • Santiago

    Santiago, 8360160

Other trials in Chile

Czechia4 sites

  • Ceské Budejovice

    České Budějovice, 370 01

  • Jihlava

    Jihlava, 586 33

  • Olomouc

    Olomouc, 772 00

  • Pisek

    Písek, 39701

Other trials in Czechia

About this study

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

The purpose of this study was to determine the long-term efficacy and safety of relugolix 40 milligrams (mg) once daily co-administered with 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 pivotal studies (MVT-601-3001 or MVT-601-3002).

Read the detailed description

This study is an international phase 3 open-label, single-arm, long-term efficacy and safety extension study that enrolled eligible participants who have completed their participation in one of the phase 3 randomized, double-blind, placebo-controlled pivotal studies, MVT-601-3001 (LIBERTY 1 - NCT03049735) or MVT-601-3002 (LIBERTY 2 - NCT 03103087). All participants received relugolix 40 mg orally once daily co-administered with E2 (1 mg) and NETA (0.5 mg) for 28 weeks.

Approximately 600 women with heavy menstrual bleeding associated with uterine fibroids were to be enrolled, after having completed a 24-week treatment period in one of the pivotal studies. The objectives of the study were to evaluate long-term efficacy and safety through up to 52 weeks of treatment (including treatment during the pivotal study) of relugolix co-administered with E2/NETA.

Screening and baseline procedures were to be done at the same visit for this extension study (referred to as the "Week 24/Baseline Visit"), which coincided with the Week 24 Visit from the pivotal study and was to be defined as the date of completion of the last Week 24 procedure in the pivotal study. Participants will have received their last dose of study drug in the pivotal study on the day prior to the Week 24/Baseline Visit and were to receive their first dose of study drug for this extension study in the clinic after the participant was determined to be eligible for this extension study and provided informed consent to participate. The administration of the first dose of study drug for MVT-601-3003 was to define enrollment into this study. Study participants were to then take the open-label study treatment orally once daily for 28 weeks.

Being tested
Relugolix, Estradiol/norethindrone acetate
Keywords
Uterine Fibroid, Heavy Menstrual Bleeding, Menstrual Blood Volume
Medical subject headings
Menorrhagia, Leiomyoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RelugolixDrug

    Also called MVT-601, TAK-385

    Relugolix 40-mg tablet administered orally once daily

  • Estradiol/norethindrone acetateDrug

    Also called E2/NETA

    Capsule containing co-formulated tablet of E2 (1 mg) and NETA (0.5 mg) administered orally once daily

Study groups in NCT03412890
Study groupRoleWhat they receive
Relugolix plus E2/NETAExperimentalRelugolix co-administered with E2/NETA for 28 weeks.
Receives: Drug: Relugolix; Drug: Estradiol/norethindrone acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage Of Participants Who Achieved Or Maintained An MBL Volume Of <80 Milliliters (mL) And At Least A 50% Reduction From Baseline MBL Volume At Week 52/End Of Treatment

    A responder was a participant who had MBL volume of < 80 mL and at least a 50% reduction from baseline MBL volume over the last 35 days of treatment (up to Week 52). All returned feminine products collected at each clinical visit were analyzed by the alkaline hematin method to obtain the MBL volume. MBL volume was measured over the Week 52/early termination feminine product collection interval (up to 35 days prior to the last dose of treatment). The percentage of participants who were responders are presented.

    Measured: Week 52/End of Treatment

Secondary outcomes (13)

  1. Change From Pivotal Study Baseline In MBL Volume At Week 52

    MBL volume was measured using the alkaline hematin method, which involves chemically measuring the blood content of used feminine products. 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 least squares (LS) mean was derived for each treatment group using a mixed-effects model with repeated measure with visit, region, and Baseline MBL as fixed effects.

    Measured: Week 52

  2. Percentage Of Participants Who Achieved Or Maintained Amenorrhea Over The Last 35 Days Of Treatment

    Amenorrhea was defined as meeting 1 of the following criteria for 2 consecutive visits:

    • No feminine product returned due to reported amenorrhea;
    • No feminine product returned due to reports of spotting/negligible bleeding coupled with other data (participant's paper diary) indicating infrequent non-cyclic bleeding/spotting; and
    • Feminine product collection with a negligible observed MBL volume coupled with data (participant's paper diary) indicating infrequent non-cyclic bleeding/spotting.

    Measured: Week 24 up to last 35 days of treatment (up to Week 52)

  3. Percentage Of Participants With A Hemoglobin Level ≤10.5 Gram/Deciliter (g/dL) At Pivotal Study Baseline Who Achieved An Increase Of >2 g/dL From Pivotal Study Baseline At Week 52

    Blood samples were collected from participants for hemoglobin measurements. Percentages are based on number of participants with hemoglobin ≤10.5 g/dL at pivotal study Baseline and reported at Week 52.

    Measured: Week 52

  4. Number Of Participants With Hemoglobin Increase Of ≥1 g/dL From Pivotal Study Baseline At Week 52 Among Those With A Hemoglobin Concentration Below Lower Limit Of Normal At Pivotal Baseline

    Blood samples were collected from participants for hemoglobin measurements. Percentages are based on number of participants with hemoglobin concentration below the lower limit of normal (11.6 g/dL) at pivotal study Baseline and reported at Week 52.

    Measured: Week 52

  5. Change From Pivotal Study Baseline In Hemoglobin Concentration At Week 52

    Blood samples were collected from participants for hemoglobin measurements. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.

    Measured: Week 52

  6. Change From Pivotal Study Baseline In The UFS-QoL Symptom Severity Scale At Week 52

    Transformed score ranges from 0 to 100 based on Likert scale (none of time, a little of time, some of the time, most of the time, and all of the time). Lower score indicates less distress and higher score indicates greater distress. A negative change from baseline indicates improvement. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.

    Measured: Week 52

  7. Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52

    Assessed using the UFS-QoL questionnaire. The UFS-QoL subscale scores include items related to uterine fibroid-associated limitations/impairment in activities, revised activities, concern, energy/mood, control, self-consciousness, and sexual function. The scores were transformed to normalized scores. Transformed score ranges from 0 to 100. Higher scores are indicative of better health-related quality of life (high = good). The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.

    Measured: Week 52

  8. Change From Pivotal Study Baseline In The UFS-QoL Score By Health-Related Quality of Life Total Score At Week 52

    Assessed using the UFS-QoL Questionnaire. The UFS-QoL total score was the sum of the subscales (concern, activities, revised activities, energy/mood, control, self-conscious, and sexual function). The raw scores were transformed to normalized scores. Transformed score ranges from 0 to 100. Higher scores are indicative of better health-related quality of life (high = good). The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.

    Measured: Week 52

  9. Change From Pivotal Study Baseline In The Uterine Fibroid Symptom Health-Related Quality of Life (UFS-QoL) Bleeding And Pelvic Discomfort (BPD) Scale At Week 52

    The BPD scale has been derived from the UFS-QoL symptom severity scale. The scale consists of the following 3 symptoms proximal to uterine fibroids that are experienced by most participants: heavy bleeding during the menstrual period (Question 1), passing blood clots during the menstrual period (Question 2), and feeling tightness or pressure in the pelvic area (Question 5). Raw scores were transformed to a normalized score, with a range of possible scores from 0 to 100 (none of time, a little of time, some of the time, most of the time, and all of the time), where higher scores values are indicative of greater distress and lower scores are indicative of minimal distress. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.

    Measured: Week 52

  10. Change From Pivotal Study Baseline In Uterine Volume At Week 52

    Volume of the uterus was measured by transvaginal or transabdominal ultrasound. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.

    Measured: Week 52

  11. Change From Pivotal Study Baseline In Uterine Fibroid Volume At Week 52

    Volume of the primary uterine fibroid was measured by transvaginal or transabdominal ultrasound. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.

    Measured: Week 52

  12. Percent Change From Pivotal 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 (DXA) scan at the lumbar spine (L1-L4), total hip, and femoral neck at pivotal study Baseline and at Week 52. The scans were read by the central radiology laboratory in accordance with the imaging charter. The same DXA machine was used at the local imaging center at each site and operated in the same scan mode for all images procured for an individual participant. All images were submitted for central reading. The central radiology laboratory collected and evaluated all DXA scans for acceptability and measured BMD. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.

    Measured: Week 52

  13. Change From Pivotal Study Baseline In Predose Serum E2 Concentrations At Week 52

    Blood samples were collected from participants at predose for E2 measurements. These were analyzed at a central laboratory.

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2018
  2. Study start19 Oct 2017
  3. Primary completion21 Jan 2020
  4. Study completion13 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open-Label Extension
Masking
None (open label)
Enrolment
477 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03412890
Sponsor's protocol ID
MVT-601-3003
Other IDs
2017-003310-74, 2017
Status last verified
Apr 2024
First submitted
19 Jan 2018
Last updated
9 May 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Stewart EA, Al-Hendy A, Lukes AS, Madueke-Laveaux OS, Zhu E, Proehl S, Schulmann T, Marsh EE. Relugolix combination therapy in Black/African American women with symptomatic uterine fibroids: LIBERTY Long-Term Extension study. Am J Obstet Gynecol. 2024 Feb;230(2):237.e1-237.e11. doi: 10.1016/j.ajog.2023.10.030. Epub 2023 Oct 18.

    PubMed 37863160

  • Al-Hendy A, Lukes AS, Venturella R, Villarroel C, McKain L, Li Y, Wagman RB, Stewart EA. A plain language summary of the long-term relugolix combination therapy study for uterine fibroids. J Comp Eff Res. 2023 Aug;12(8):e230069. doi: 10.57264/cer-2023-0069. Epub 2023 Jul 21.

    PubMed 37477173

  • Al-Hendy A, Lukes AS, Poindexter AN 3rd, Venturella R, Villarroel C, McKain L, Li Y, Wagman RB, Stewart EA. Long-term Relugolix Combination Therapy for Symptomatic Uterine Leiomyomas. Obstet Gynecol. 2022 Dec 1;140(6):920-930. doi: 10.1097/AOG.0000000000004988. Epub 2022 Nov 2.

    PubMed 36357960

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Relugolix and Estradiol/norethindrone acetate in people with Heavy Menstrual Bleeding and Uterine Fibroid, run by Myovant Sciences GmbH at 150 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 150 sites in United States, Brazil, Poland, South Africa, Hungary and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Of Participants Who Achieved Or Maintained An MBL Volume Of <80 Milliliters (mL) And At Least A 50% Reduction From Baseline MBL Volume At Week 52/End Of Treatment (time frame: Week 52/End of Treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03412890, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.

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