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Uterine FibroidsPhase 3NCT05862272

A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis

A Phase 3 study testing Relugolix Combination Tablet in people with Uterine Fibroids and Endometriosis, run by Sumitomo Pharma Switzerland GmbH at 120 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this clinical trial to characterize changes in bone mineral density during continuous treatment with relugolix combination tablet for up to 48 months (4 years) and 1 year of post-treatment follow-up in premenopausal women with heavy menstrual bleeding associated with uterine leiomyomas (fibroids) or… Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Uterine Fibroids, Endometriosis
What is being tested?
Relugolix Combination Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
120 sitesUnited States
Study dates
14 Aug 2023to Sep 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Is a premenopausal woman, 18 to 50 years of age (inclusive);
  • A diagnosis of uterine fibroids confirmed by imaging or review of medical records and reports heavy menstrual bleeding negatively affecting quality of life. or
  • A diagnosis of endometriosis that is associated with moderate to severe pain.;
  • If at risk of pregnancy is willing to avoid pregnancy for 4 years (the duration of the treatment period) using nonhormonal methods of contraception.
  • Has a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at the allocation visit (or Month 12 if entering from MVT-601-050 [NCT04756037; SERENE]);
  • In good physical and mental health based on medical, surgical, and gynecological history as well as physical, gynecological, and breast examinations, clinical laboratory test results, and vital sign measurements;
  • Has a body mass index ≥ 18 kg/m^2.

Who cannot join

  • Has a weight or body habitus that exceeds the limit of the DXA scanner or has a condition that precludes an adequate DXA measurement at the lumbar spine or proximal femur
  • Has a DXA result demonstrating the following criteria at any anatomic site (lumbar spine, total hip, femoral neck):
  • For patients entering de novo a Z-score ≤ -1.5 or T-score ≤ -2.0 (if ≥ 40 years of age)
  • For patients entering from MVT-601-050 (NCT04756037; SERENE) a 12-month on-treatment DXA demonstrating Z-score ≤ -2.0, T-score ≤ -2.5 (if ≥ 40 years of age), or BMD loss ≥ 8% compared with pre-treatment baseline;
  • Screening 25-OH vitamin D level < 12 ng/mL (patients with 25-OH vitamin D deficiency with levels ≥ 12 to < 20 ng/mL are permitted if supplementing with vitamin D or if vitamin D supplementation is started in the screening period);
  • Has a history of or currently has Cushing's Syndrome, Rheumatoid Arthritis, metabolic bone disease, uncorrected hyperparathyroidism, Paget's disease of the bone, collagen vascular disease, Marfan's syndrome, Ehlers-Danlos syndrome (if confirmed on genetic testing or meets definitive criteria for hypermobility type), chronic kidney disease (CKD) stage 3 or greater with glomerular filtration rate (GFR) < 60 mL/min/m2 using Modification of Diet in Renal Disease (MDRD) method, hyperprolactinemia, known pituitary adenoma, hyperthyroidism, anorexia nervosa, bulimia (within the last year), abnormal bone mineral metabolism (eg, hypophosphatemia). Patients whose hyperparathyroidism or hyperthyroidism has been successfully treated or whose hyperprolactinemia has been successfully treated are allowed;
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  • History of low trauma (fragility) fracture.
  • Past history of use or current use of medication used to treat bone loss other than calcium and vitamin D preparations;
  • Prior use of depot-medroxyprogesterone acetate for a treatment period > 2 years (if treatment occurred within the past 5 years) or prior use of GnRH agonist or antagonist for > 12 months total (unless directly entering from MVT-601-050 [NCT04756037; SERENE]);
  • Malabsorptive disease (including, but not limited to, inflammatory bowel disease and gastric bypass surgery);
  • Current breast cancer, history of breast cancer or other hormone-sensitive malignancy, at increased risk for hormone-sensitive malignancy, or taking an aromatase inhibitor for breast cancer treatment or prevention
  • History of organ transplantation or history of bone marrow
  • BIRADS ≥ 3 Mammogram at entry (or within the past 6 months).
  • Has a known human immunodeficiency virus (HIV) infection or at high risk of contracting HIV
  • Has a current psychiatric disorder that would, in the investigator or medical monitor's opinion, impair the ability of the patient to participate in the study or would impair interpretation of their data.
  • Is currently using a hormonal intrauterine device or contraceptive implant, hormonal contraceptive, or other prohibited medication and is unwilling to discontinue this hormonal contraception

Trial locations and contacts

120 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials at Myovant contact

650-278-8743

ClinicalTrials@Myovant.com

120 sites in 1 country

United States120 sites, 120 recruiting

  • Annandale

    Annandale, Virginia, 22003-7308

    Recruiting

  • Arlington

    Arlington, Texas, 76012-4705

    Recruiting

  • Atlanta

    Atlanta, Georgia, 30342

    Recruiting

  • Atlanta

    Atlanta, Georgia, 30363

    Recruiting

  • Aurora

    Aurora, Colorado, 80045-2517

    Recruiting

  • Aventura

    Aventura, Florida, 33180

    Recruiting

  • Baltimore

    Baltimore, Maryland, 21205

    Recruiting

  • Bay City

    Bay City, Michigan, 48706

    Recruiting

  • Bluffton

    Bluffton, South Carolina, 29910-4883

    Recruiting

  • Burbank

    Burbank, California, 91506-1773

    Recruiting

  • Canoga Park

    Canoga Park, California, 91303

    Recruiting

  • Chandler

    Chandler, Arizona, 85224

    Recruiting

  • Chattanooga

    Chattanooga, Tennessee, 37404

    Recruiting

  • Chicago

    Chicago, Illinois, 60607-4911

    Recruiting

  • Chicago

    Chicago, Illinois, 60616

    Recruiting

  • Cincinnati

    Cincinnati, Ohio, 45255

    Recruiting

  • Cleveland

    Cleveland, Ohio, 44124

    Recruiting

  • College Park

    College Park, Georgia, 30349-3103

    Recruiting

  • Columbus

    Columbus, Ohio, 43213

    Recruiting

  • Columbus

    Columbus, Ohio, 43231

    Recruiting

  • Covington

    Covington, Louisiana, 70433

    Recruiting

  • Dallas

    Dallas, Texas, 75230-2598

    Recruiting

  • Dallas

    Dallas, Texas, 75230

    Recruiting

  • Dearborn Heights

    Dearborn Heights, Michigan, 48127

    Recruiting

  • Deland

    DeLand, Florida, 32720

    Recruiting

  • Detroit

    Detroit, Michigan, 48201

    Recruiting

  • Dublin

    Dublin, Ohio, 43016

    Recruiting

  • Durham

    Durham, North Carolina, 27713

    Recruiting

  • Encinitas

    Encinitas, California, 92024-1329

    Recruiting

  • Englewood

    Englewood, Ohio, 45322

    Recruiting

  • Erie

    Erie, Pennsylvania, 16507-1423

    Recruiting

  • Fayetteville

    Fayetteville, Georgia, 31204

    Recruiting

  • Fort Worth

    Fort Worth, Texas, 76104-4141

    Recruiting

  • Galveston

    Galveston, Texas, 77555

    Recruiting

  • Grand Island

    Grand Island, Nebraska, 68803-4327

    Recruiting

  • Greenville

    Greenville, South Carolina, 29615-4833

    Recruiting

  • Greenwood Village

    Greenwood Village, Colorado, 80111

    Recruiting

  • Hialeah

    Hialeah, Florida, 33016

    Recruiting

  • Houston

    Houston, Texas, 77021

    Recruiting

  • Houston

    Houston, Texas, 77024

    Recruiting

  • Houston

    Houston, Texas, 77030-4514

    Recruiting

  • Houston

    Houston, Texas, 77054

    Recruiting

  • Idaho Falls

    Idaho Falls, Idaho, 83404-8322

    Recruiting

  • Idaho Falls

    Idaho Falls, Idaho, 83404

    Recruiting

  • Inglewood

    Inglewood, California, 90301

    Recruiting

  • Jackson

    Jackson, Tennessee, 38305

    Recruiting

  • Kissimmee

    Kissimmee, Florida, 34741-2358

    Recruiting

  • Lake Worth

    Lake Worth, Florida, 33461

    Recruiting

  • Lakewood

    Lakewood, Colorado, 80228

    Recruiting

  • Las Vegas

    Las Vegas, Nevada, 89109

    Recruiting

  • Laurel

    Laurel, Maryland, 20707-5203

    Recruiting

  • League City

    League City, Texas, 77573

    Recruiting

  • Lenexa

    Lenexa, Kansas, 66215-2733

    Recruiting

  • Lomita

    Lomita, California, 90717-2101

    Recruiting

  • Long Beach

    Long Beach, California, 90805-4587

    Recruiting

  • Los Angeles

    Los Angeles, California, 90036

    Recruiting

  • Margate

    Margate, Florida, 33063-5715

    Recruiting

  • Marrero

    Marrero, Louisiana, 70072

    Recruiting

  • Memphis

    Memphis, Tennessee, 38119

    Recruiting

  • Memphis

    Memphis, Tennessee, 38120

    Recruiting

  • Meridian

    Meridian, Idaho, 83646

    Recruiting

  • Mesa

    Mesa, Arizona, 85209

    Recruiting

  • Metairie

    Metairie, Louisiana, 70001

    Recruiting

  • Miami

    Miami, Florida, 33126

    Recruiting

  • Miami

    Miami, Florida, 33155

    Recruiting

  • Miami

    Miami, Florida, 33173

    Recruiting

  • Miami Beach

    Miami Beach, Florida, 33140

    Recruiting

  • Miami Springs

    Miami Springs, Florida, 33166

    Recruiting

  • Middletown

    Middletown, Ohio, 45005-2593

    Recruiting

  • Mobile

    Mobile, Alabama, 36604

    Recruiting

  • New Bern

    New Bern, North Carolina, 28562

    Recruiting

  • New Orleans

    New Orleans, Louisiana, 70115-6235

    Recruiting

  • New Orleans

    New Orleans, Louisiana, 70127

    Recruiting

  • New Port Richey

    New Port Richey, Florida, 34652-4020

    Recruiting

  • New Port Richey

    New Port Richey, Florida, 34652

    Recruiting

  • Newport News

    Newport News, Virginia, 23606

    Recruiting

  • Norcross

    Norcross, Georgia, 30093

    Recruiting

  • Norfolk

    Norfolk, Nebraska, 68701

    Recruiting

  • North Las Vegas

    North Las Vegas, Nevada, 89030

    Recruiting

  • Orlando

    Orlando, Florida, 32808

    Recruiting

  • Orlando

    Orlando, Florida, 32819

    Recruiting

  • Panama City

    Panama City, Florida, 32405

    Recruiting

  • Pearland

    Pearland, Texas, 77584

    Recruiting

  • Peoria

    Peoria, Arizona, 85381

    Recruiting

  • Philadelphia

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Philadelphia

    Philadelphia, Pennsylvania, 19114

    Recruiting

  • Phoenix

    Phoenix, Arizona, 85018

    Recruiting

  • Pleasant Grove

    Pleasant Grove, Utah, 84062-4097

    Recruiting

  • Raleigh

    Raleigh, North Carolina, 27607

    Recruiting

  • Raleigh

    Raleigh, North Carolina, 27612-8104

    Recruiting

  • Ridgeland

    Ridgeland, Mississippi, 39157-5179

    Recruiting

  • Sacramento

    Sacramento, California, 95817-2307

    Recruiting

  • Salt Lake City

    Salt Lake City, Utah, 84107

    Recruiting

  • San Antonio

    San Antonio, Texas, 78230

    Recruiting

  • San Antonio

    San Antonio, Texas, 78258

    Recruiting

  • San Fernando

    San Fernando, California, 91340-4199

    Recruiting

  • Sarasota

    Sarasota, Florida, 34239

    Recruiting

  • Schaumburg

    Schaumburg, Illinois, 60173-5831

    Recruiting

  • Seattle

    Seattle, Washington, 98105-4028

    Recruiting

  • Slidell

    Slidell, Louisiana, 70458-2004

    Recruiting

  • Saint Louis

    St Louis, Missouri, 63108-1495

    Recruiting

  • St Louis

    St Louis, Missouri, 63141

    Recruiting

  • Stanford

    Stanford, California, 94305-2200

    Recruiting

  • Sugar Land

    Sugar Land, Texas, 77479-1001

    Recruiting

  • Sugar Land

    Sugar Land, Texas, 77479

    Recruiting

  • Summerville

    Summerville, South Carolina, 29485-8345

    Recruiting

  • Tamarac

    Tamarac, Florida, 33321

    Recruiting

  • Tampa

    Tampa, Florida, 33614-1874

    Recruiting

  • Towson

    Towson, Maryland, 21204

    Recruiting

  • Tucson

    Tucson, Arizona, 85715-3834

    Recruiting

  • Valley Village

    Valley Village, California, 91607

    Recruiting

  • Venice

    Venice, Florida, 34285

    Recruiting

  • Virginia Beach

    Virginia Beach, Virginia, 23456-8125

    Recruiting

  • Washington

    Washington D.C., District of Columbia, 02011

    Recruiting

  • Webster

    Webster, Texas, 77598-4081

    Recruiting

  • West Columbia

    West Columbia, South Carolina, 29169

    Recruiting

  • West New York

    West New York, New Jersey, 07093-2622

    Recruiting

  • West Palm Beach

    West Palm Beach, Florida, 33409

    Recruiting

  • Wichita

    Wichita, Kansas, 67211

    Recruiting

  • Winston Salem

    Winston-Salem, North Carolina, 27103-1749

    Recruiting

Other trials in United States

About this study

Official title: A Phase 3B, Single-Arm, Open-Label Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids or Moderate to Severe Pain Associated With Endometriosis

The purpose of this clinical trial to characterize changes in bone mineral density during continuous treatment with relugolix combination tablet for up to 48 months (4 years) and 1 year of post-treatment follow-up in premenopausal women with heavy menstrual bleeding associated with uterine leiomyomas (fibroids) or with moderate-to-severe pain associated with endometriosis.

Read the detailed description

A prospective, single-arm, open-label, Phase 3B study to assess the effect of continuous 48 months (4 years) of treatment with relugolix combination tablet (relugolix 40 mg/estradiol [E2] 1 mg/norethindrone acetate [NETA] 0.5 mg) on bone mineral density in premenopausal women with heavy menstrual bleeding associated with uterine leiomyomas (fibroids) and premenopausal women with moderate to severe pain associated with endometriosis.

Approximately 1000 women (500 with heavy menstrual bleeding associated with uterine fibroids and 500 with moderate to severe pain associated with endometriosis) will receive relugolix combination tablet, during which time BMD will be assessed by dual-energy X-ray absorptiometry every 6 months.

A subset of participants will be eligible to enter this study following completion of 1 year of treatment with relugolix combination therapy in MVT-601-050 (NCT04756037; SERENE) and will complete 3 years of treatment under this protocol.

Upon completion of 48 months (4 years) of treatment or after early termination of treatment, participants will enter a 1-year post-treatment follow-up period during which time bone mineral density will be assessed at Month 6 and Month 12 following treatment cessation.

Being tested
Relugolix Combination Tablet
Keywords
Uterine Leiomyomas, Fibroids, Endometriosis, Bone Mineral Density, Relugolix, Estradiol, Norethindrone acetate
Medical subject headings
Leiomyoma, Endometriosis, Myofibroma

What participants receive

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

  • Relugolix Combination TabletDrug

    Also called TAK-385, T-1331285, RVT-601, MVT-601

    A fixed-dose combination tablet containing relugolix 40 mg, estradiol (E2) 1 mg, and norethindrone acetate (NETA) 0.5 mg.

Study groups in NCT05862272
Study groupRoleWhat they receive
Relugolix Combination TabletExperimentalParticipants will receive relugolix combination therapy orally once daily for 48 months.
Receives: Drug: Relugolix Combination Tablet

What is being measured

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

  1. Percent change from baseline in BMD (bone mineral density) at Month 48 on-treatment at lumbar spine (L1-L4) in women with uterine fibroids.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan.

    Measured: Baseline up to Month 48

  2. Percent change from baseline in BMD at Month 48 on-treatment at lumbar spine (L1-L4) in women with endometriosis.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan.

    Measured: Baseline up to Month 48

Secondary outcomes (15)

  1. Percent change from baseline in BMD at Month 48 on-treatment at total hip and femoral neck in women with uterine fibroids.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan.

    Measured: Baseline up to Month 48

  2. Percent change from baseline in BMD at Month 48 on-treatment at total hip and femoral neck in women with endometriosis.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan.

    Measured: Baseline up to Month 48

  3. Percent change from baseline in BMD at Month 6, 12, 18, 24, 30, 36, and 42 on-treatment at the lumbar spine (L1-L4), total hip, and femoral neck in women with uterine fibroids.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.

    Measured: Baseline up to Month 6, 12, 18, 24, 30, 36, and 42

  4. Percent change from baseline in BMD at Month 6, 12, 18, 24, 30, 36, and 42 on-treatment at the lumbar spine (L1-L4), total hip, and femoral neck in women with endometriosis.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.

    Measured: Baseline up to Month 6, 12, 18, 24, 30, 36, and 42

  5. Percent change from baseline in BMD at Month 48 on-treatment at lumbar spine (L1-L4) in the overall study population.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.

    Measured: Baseline up to Month 48

  6. Percent change from baseline in BMD at Month 48 on-treatment at total hip and femoral neck in the overall study population.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.

    Measured: Baseline up to Month 48

  7. Percent change from baseline in BMD at Month 6, 12, 18, 24, 30, 36, and 42 on-treatment at the lumbar spine (L1-L4), total hip, and femoral neck in the overall study population.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.

    Measured: Baseline up to Month 6, 12, 18, 24, 30, 36, and 42

  8. Percent change from baseline in BMD at post-treatment follow-up (PTFU) Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in women with uterine fibroids.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.

    Measured: 6 months and 12 months post treatment

  9. Percent change from baseline in BMD at PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in women with endometriosis.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.

    Measured: 6 months and 12 months post treatment

  10. Percent change from last on-treatment BMD measurement to PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in women with uterine fibroids.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.

    Measured: 6 months and 12 months post treatment

  11. Percent change from last on-treatment BMD measurement to PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in women with endometriosis.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.

    Measured: 6 months and 12 months post treatment

  12. Percent change from baseline in BMD at PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in the overall study population.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.

    Measured: 6 months and 12 months post treatment

  13. Percent change from last on-treatment BMD measurement to PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in the overall study population.

    Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.

    Measured: 6 months and 12 months post treatment

  14. Incidence of treatment-emergent serious adverse events, and non-serious adverse events leading to treatment discontinuation or withdrawal from the study during the 48 months of treatment.

    Safety analyses will be conducted by each safety population: 1) women with uterine fibroids, 2) women with endometriosis, and 3) overall population. The treatment-emergent period will be defined as the period of time from the date of the first dose of the study drug through 14 days after the last dose of study drug, or the date of initiation of another investigational agent or hormonal therapy affecting the hypothalamic-pituitary gonadal axis or surgical intervention for uterine fibroids or for endometriosis, whichever occurs first.

    Measured: Baseline up to Month 48

  15. Incidence and location of fractures during the 48 months on treatment and 12 months PTFU.

    Safety analyses will be conducted by each safety population: 1) women with uterine fibroids, 2) women with endometriosis, and 3) overall population. All adverse events will be coded to preferred term and system organ class using Medical Dictionary for Regulatory Activities (MedDRA) version 24.0 or higher. The incidence of fractures will also be summarized by anatomical sites and whether the fracture qualifies as a fragility fracture. A participant reporting the same adverse event more than once is counted once, and at the maximum severity or strongest relationship to study drug treatment when calculating incidence.

    Measured: Baseline up to Month 48 and 12 months post treatment

Timeline

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

  1. First posted17 May 2023
  2. Study start14 Aug 2023
  3. Primary completionJul 2029 (estimated)
  4. Study completionSep 2030 (estimated)

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
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05862272
Sponsor's protocol ID
MVT-601A-006
Status last verified
Jul 2025
First submitted
8 May 2023
Last updated
6 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Relugolix Combination Tablet in people with Uterine Fibroids and Endometriosis, run by Sumitomo Pharma Switzerland GmbH at 120 sites in United States.

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 7 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in United States. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Clinical Trials at Myovant (650-278-8743, ClinicalTrials@Myovant.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change from baseline in BMD (bone mineral density) at Month 48 on-treatment at lumbar spine (L1-L4) in women with uterine fibroids. (time frame: Baseline up to Month 48). The study lists 2 primary outcomes in all. 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 NCT05862272.

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 6 Aug 2025.

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