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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified June 2025 by Sumitomo Pharma Switzerland GmbH
Sponsor
Sumitomo Pharma Switzerland GmbH
Information Provided by (Responsible Party)
Sumitomo Pharma Switzerland GmbH
Clinicaltrials.gov Identifier
NCT05862272
Other Study ID Numbers:
MVT-601A-006
First Submitted
May 7, 2023
First Posted
May 16, 2023
Last Update Posted
August 5, 2025
Last Verified
June 2025

ClinicalTrials.gov processed this data on July 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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.

Condition or DiseaseIntervention/Treatment
Uterine FibroidsEndometriosis
Drug: Relugolix Combination Tablet

Study Design

Study TypeInterventional
Actual Enrollment1000 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA 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
Study Start DateAugust 13, 2023
Actual Primary Completion Date3yrs 1mo from now
Actual Study Completion Date4yrs 3mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Relugolix Combination Tablet
Participants will receive relugolix combination therapy orally once daily for 48 months.
Drug: Relugolix Combination Tablet
A fixed-dose combination tablet containing relugolix 40 mg, estradiol (E2) 1 mg, and norethindrone acetate (NETA) 0.5 mg.

Outcome Measures

Primary Outcome Measures
  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.
  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.
Secondary Outcome Measures
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  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.
  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.

Eligibility Criteria

Ages Eligible for Study(Adult)
Sexes Eligible for StudyFemale
Accepts Healthy VolunteersNo
Inclusion Criteria
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. Key
Exclusion Criteria
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): 1. For patients entering de novo a Z-score ≤ -1.5 or T-score ≤ -2.0 (if ≥ 40 years of age) 2. 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;
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

Contacts and Locations

Sponsors and CollaboratorsSumitomo Pharma Switzerland GmbH
Locations
Mobile | Mobile Alabama, United States, 36604Chandler | Chandler Arizona, United States, 85224Mesa | Mesa Arizona, United States, 85209Peoria | Peoria Arizona, United States, 85381Phoenix | Phoenix Arizona, United States, 85018Tucson | Tucson Arizona, United States, 85715-3834Burbank | Burbank California, United States, 91506-1773Canoga Park | Canoga Park California, United States, 91303Encinitas | Encinitas California, United States, 92024-1329Inglewood | Inglewood California, United States, 90301Lomita | Lomita California, United States, 90717-2101Long Beach | Long Beach California, United States, 90805-4587Los Angeles | Los Angeles California, United States, 90036Sacramento | Sacramento California, United States, 95817-2307San Fernando | San Fernando California, United States, 91340-4199Stanford | Stanford California, United States, 94305-2200Valley Village | Valley Village California, United States, 91607Aurora | Aurora Colorado, United States, 80045-2517Greenwood Village | Greenwood Village Colorado, United States, 80111Lakewood | Lakewood Colorado, United States, 80228Washington | Washington D.C. District of Columbia, United States, 02011Aventura | Aventura Florida, United States, 33180Deland | DeLand Florida, United States, 32720Hialeah | Hialeah Florida, United States, 33016Kissimmee | Kissimmee Florida, United States, 34741-2358Lake Worth | Lake Worth Florida, United States, 33461Margate | Margate Florida, United States, 33063-5715Miami | Miami Florida, United States, 33126Miami | Miami Florida, United States, 33155Miami | Miami Florida, United States, 33173Miami Beach | Miami Beach Florida, United States, 33140Miami Springs | Miami Springs Florida, United States, 33166New Port Richey | New Port Richey Florida, United States, 34652-4020New Port Richey | New Port Richey Florida, United States, 34652Orlando | Orlando Florida, United States, 32808Orlando | Orlando Florida, United States, 32819Panama City | Panama City Florida, United States, 32405Sarasota | Sarasota Florida, United States, 34239Tamarac | Tamarac Florida, United States, 33321Tampa | Tampa Florida, United States, 33614-1874Venice | Venice Florida, United States, 34285West Palm Beach | West Palm Beach Florida, United States, 33409Atlanta | Atlanta Georgia, United States, 30342Atlanta | Atlanta Georgia, United States, 30363College Park | College Park Georgia, United States, 30349-3103Fayetteville | Fayetteville Georgia, United States, 31204Norcross | Norcross Georgia, United States, 30093Idaho Falls | Idaho Falls Idaho, United States, 83404-8322Idaho Falls | Idaho Falls Idaho, United States, 83404Meridian | Meridian Idaho, United States, 83646Chicago | Chicago Illinois, United States, 60607-4911Chicago | Chicago Illinois, United States, 60616Schaumburg | Schaumburg Illinois, United States, 60173-5831Lenexa | Lenexa Kansas, United States, 66215-2733Wichita | Wichita Kansas, United States, 67211Covington | Covington Louisiana, United States, 70433Marrero | Marrero Louisiana, United States, 70072Metairie | Metairie Louisiana, United States, 70001New Orleans | New Orleans Louisiana, United States, 70115-6235New Orleans | New Orleans Louisiana, United States, 70127Slidell | Slidell Louisiana, United States, 70458-2004Baltimore | Baltimore Maryland, United States, 21205Laurel | Laurel Maryland, United States, 20707-5203Towson | Towson Maryland, United States, 21204Bay City | Bay City Michigan, United States, 48706Dearborn Heights | Dearborn Heights Michigan, United States, 48127Detroit | Detroit Michigan, United States, 48201Ridgeland | Ridgeland Mississippi, United States, 39157-5179Saint Louis | St Louis Missouri, United States, 63108-1495St Louis | St Louis Missouri, United States, 63141Grand Island | Grand Island Nebraska, United States, 68803-4327Norfolk | Norfolk Nebraska, United States, 68701Las Vegas | Las Vegas Nevada, United States, 89109North Las Vegas | North Las Vegas Nevada, United States, 89030West New York | West New York New Jersey, United States, 07093-2622Durham | Durham North Carolina, United States, 27713New Bern | New Bern North Carolina, United States, 28562Raleigh | Raleigh North Carolina, United States, 27607Raleigh | Raleigh North Carolina, United States, 27612-8104Winston Salem | Winston-Salem North Carolina, United States, 27103-1749Cincinnati | Cincinnati Ohio, United States, 45255Cleveland | Cleveland Ohio, United States, 44124Columbus | Columbus Ohio, United States, 43213Columbus | Columbus Ohio, United States, 43231Dublin | Dublin Ohio, United States, 43016Englewood | Englewood Ohio, United States, 45322Middletown | Middletown Ohio, United States, 45005-2593Erie | Erie Pennsylvania, United States, 16507-1423Philadelphia | Philadelphia Pennsylvania, United States, 19104Philadelphia | Philadelphia Pennsylvania, United States, 19114Bluffton | Bluffton South Carolina, United States, 29910-4883Greenville | Greenville South Carolina, United States, 29615-4833Summerville | Summerville South Carolina, United States, 29485-8345West Columbia | West Columbia South Carolina, United States, 29169Chattanooga | Chattanooga Tennessee, United States, 37404Jackson | Jackson Tennessee, United States, 38305Memphis | Memphis Tennessee, United States, 38119Memphis | Memphis Tennessee, United States, 38120Arlington | Arlington Texas, United States, 76012-4705Dallas | Dallas Texas, United States, 75230-2598Dallas | Dallas Texas, United States, 75230Fort Worth | Fort Worth Texas, United States, 76104-4141Galveston | Galveston Texas, United States, 77555Houston | Houston Texas, United States, 77021Houston | Houston Texas, United States, 77024Houston | Houston Texas, United States, 77030-4514Houston | Houston Texas, United States, 77054League City | League City Texas, United States, 77573Pearland | Pearland Texas, United States, 77584San Antonio | San Antonio Texas, United States, 78230San Antonio | San Antonio Texas, United States, 78258Sugar Land | Sugar Land Texas, United States, 77479-1001Sugar Land | Sugar Land Texas, United States, 77479Webster | Webster Texas, United States, 77598-4081Pleasant Grove | Pleasant Grove Utah, United States, 84062-4097Salt Lake City | Salt Lake City Utah, United States, 84107Annandale | Annandale Virginia, United States, 22003-7308Newport News | Newport News Virginia, United States, 23606Virginia Beach | Virginia Beach Virginia, United States, 23456-8125Seattle | Seattle Washington, United States, 98105-4028
Investigators
Study Director: Myovant Medical Director, Myovant Sciences GmbH