RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-08-14
Study Completion:2030-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05862272

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.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Is a premenopausal woman, 18 to 50 years of age (inclusive);
  2. * A diagnosis of uterine fibroids confirmed by imaging or review of medical records and reports heavy menstrual bleeding negatively affecting quality of life. or
  3. * A diagnosis of endometriosis that is associated with moderate to severe pain.;
  4. * If at risk of pregnancy is willing to avoid pregnancy for 4 years (the duration of the treatment period) using nonhormonal methods of contraception.
  5. * 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 \[NCT04756037; SERENE\]);
  6. * 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;
  7. * Has a body mass index ≥ 18 kg/m\^2.
  1. * 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
  2. * Has a DXA result demonstrating the following criteria at any anatomic site (lumbar spine, total hip, femoral neck):
  3. 1. For patients entering de novo a Z-score ≤ -1.5 or T-score ≤ -2.0 (if ≥ 40 years of age)
  4. 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;
  5. * 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);
  6. * 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;
  7. * History of low trauma (fragility) fracture.
  8. * Past history of use or current use of medication used to treat bone loss other than calcium and vitamin D preparations;
  9. * 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 \[NCT04756037; SERENE\]);
  10. * Malabsorptive disease (including, but not limited to, inflammatory bowel disease and gastric bypass surgery);
  11. * 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
  12. * History of organ transplantation or history of bone marrow
  13. * BIRADS ≥ 3 Mammogram at entry (or within the past 6 months).
  14. * Has a known human immunodeficiency virus (HIV) infection or at high risk of contracting HIV
  15. * 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.
  16. * 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

Study Contact

Clinical Trials at Myovant
CONTACT
650-278-8743
ClinicalTrials@Myovant.com

Principal Investigator

Myovant Medical Director
STUDY_DIRECTOR
Myovant Sciences GmbH

Study Locations (Sites)

Mobile
Mobile, Alabama, 36604
United States
Chandler
Chandler, Arizona, 85224
United States
Mesa
Mesa, Arizona, 85209
United States
Phoenix
Phoenix, Arizona, 85018
United States
Tucson
Tucson, Arizona, 85715-3834
United States
Canoga Park
Canoga Park, California, 91303
United States
Encinitas
Encinitas, California, 92024-1329
United States
Inglewood
Inglewood, California, 90301
United States
Long Beach
Long Beach, California, 90805-4587
United States
Los Angeles
Los Angeles, California, 90036
United States
Palo Alto
Palo Alto, California, 94304
United States
Valley Village
Valley Village, California, 91607
United States
Greenwood Village
Greenwood Village, Colorado, 80111
United States
Lakewood
Lakewood, Colorado, 80228
United States
Washington
Washington, District of Columbia, 02011
United States
Aventura
Aventura, Florida, 33180
United States
Deland
Deland, Florida, 32720
United States
Hialeah
Hialeah, Florida, 33016
United States
Kissimmee
Kissimmee, Florida, 34741-2358
United States
Lake Worth
Lake Worth, Florida, 33461
United States
Margate
Margate, Florida, 33063-5715
United States
Miami Springs
Miami Springs, Florida, 33166
United States
Miami
Miami, Florida, 33126
United States
Miami
Miami, Florida, 33155
United States
Miami
Miami, Florida, 33173
United States
New Port Richey
New Port Richey, Florida, 34652
United States
Orlando
Orlando, Florida, 32819
United States
Panama City
Panama City, Florida, 32405
United States
Sarasota
Sarasota, Florida, 34239
United States
Tamarac
Tamarac, Florida, 33321
United States
Tampa
Tampa, Florida, 33614-1874
United States
Venice
Venice, Florida, 34285
United States
West Palm Beach
West Palm Beach, Florida, 33409
United States
Atlanta
Atlanta, Georgia, 30342
United States
Atlanta
Atlanta, Georgia, 30363
United States
College Park
College Park, Georgia, 30349-3103
United States
Norcross
Norcross, Georgia, 30093
United States
Savannah
Savannah, Georgia, 31406
United States
Smyrna
Smyrna, Georgia, 30082
United States
Idaho Falls
Idaho Falls, Idaho, 83404
United States
Meridian
Meridian, Idaho, 83646
United States
Chicago
Chicago, Illinois, 60616
United States
Shawnee
Shawnee, Kansas, 66218
United States
Wichita
Wichita, Kansas, 67211
United States
Marrero
Marrero, Louisiana, 70072
United States
Metairie
Metairie, Louisiana, 70001
United States
New Orleans
New Orleans, Louisiana, 70127
United States
Slidell
Slidell, Louisiana, 70458-2004
United States
Towson
Towson, Maryland, 21204
United States
Bay City
Bay City, Michigan, 48706
United States
Dearborn Heights
Dearborn Heights, Michigan, 48127
United States
Jackson
Jackson, Mississippi, 39202
United States
St Louis
St Louis, Missouri, 63141
United States
Grand Island
Grand Island, Nebraska, 68803-4327
United States
Norfolk
Norfolk, Nebraska, 68701
United States
Las Vegas
Las Vegas, Nevada, 89109
United States
North Las Vegas
North Las Vegas, Nevada, 89030
United States
Passaic
Passaic, New Jersey, 07055
United States
Durham
Durham, North Carolina, 27713
United States
New Bern
New Bern, North Carolina, 28562
United States
Raleigh
Raleigh, North Carolina, 27607
United States
Raleigh
Raleigh, North Carolina, 27612-8104
United States
Winston Salem
Winston Salem, North Carolina, 27103-1749
United States
Cincinnati
Cincinnati, Ohio, 45255
United States
Cleveland
Cleveland, Ohio, 44124
United States
Columbus
Columbus, Ohio, 43213
United States
Columbus
Columbus, Ohio, 43231
United States
Dublin
Dublin, Ohio, 43016
United States
Englewood
Englewood, Ohio, 45322
United States
Erie
Erie, Pennsylvania, 16507-1423
United States
Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Philadelphia
Philadelphia, Pennsylvania, 19114
United States
West Columbia
West Columbia, South Carolina, 29169
United States
Chattanooga
Chattanooga, Tennessee, 37404
United States
Jackson
Jackson, Tennessee, 38305
United States
Memphis
Memphis, Tennessee, 38119
United States
Memphis
Memphis, Tennessee, 38120
United States
Arlington
Arlington, Texas, 76012-4705
United States
Dallas
Dallas, Texas, 75230
United States
Houston
Houston, Texas, 77021
United States
Houston
Houston, Texas, 77024
United States
Houston
Houston, Texas, 77054
United States
League City
League City, Texas, 77573
United States
Pearland
Pearland, Texas, 77584
United States
San Antonio
San Antonio, Texas, 78258
United States
Sugar Land
Sugar Land, Texas, 77479
United States
Webster
Webster, Texas, 77598-4081
United States
Draper
Draper, Utah, 84020
United States
Salt Lake City
Salt Lake City, Utah, 84107
United States
Newport News
Newport News, Virginia, 23606
United States
Norfolk
Norfolk, Virginia, 23502
United States
Reston
Reston, Virginia, 22003
United States
Seattle
Seattle, Washington, 98105-4028
United States

Collaborators and Investigators

Sponsor: Sumitomo Pharma Switzerland GmbH

  • Myovant Medical Director, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2023-08-14
Study Completion Date2030-09

Study Record Updates

Study Start Date2023-08-14
Study Completion Date2030-09

Terms related to this study

Keywords Provided by Researchers

  • Uterine Leiomyomas
  • Fibroids
  • Endometriosis
  • Bone Mineral Density
  • Relugolix
  • Estradiol
  • Norethindrone acetate

Additional Relevant MeSH Terms

  • Uterine Fibroids
  • Endometriosis