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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
Key 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
Primary outcome measure(s)
Percent change from baseline in BMD (bone mineral density) at Month 48 on-treatment at lumbar spine (L1-L4) in women with uterine fibroids. — Baseline up to Month 48 Assessed by dual-energy X-ray absorptiometry (DXA) scan.
Percent change from baseline in BMD at Month 48 on-treatment at lumbar spine (L1-L4) in women with endometriosis. — Baseline up to Month 48 Assessed by dual-energy X-ray absorptiometry (DXA) scan.
Trial sites (120)
Facility
City
Region
Status
Mobile
Mobile
Alabama
Recruiting
Chandler
Chandler
Arizona
Recruiting
Mesa
Mesa
Arizona
Recruiting
Peoria
Peoria
Arizona
Recruiting
Phoenix
Phoenix
Arizona
Recruiting
Tucson
Tucson
Arizona
Recruiting
Burbank
Burbank
California
Recruiting
Canoga Park
Canoga Park
California
Recruiting
Encinitas
Encinitas
California
Recruiting
Inglewood
Inglewood
California
Recruiting
Lomita
Lomita
California
Recruiting
Long Beach
Long Beach
California
Recruiting
Los Angeles
Los Angeles
California
Recruiting
Sacramento
Sacramento
California
Recruiting
San Fernando
San Fernando
California
Recruiting
Stanford
Stanford
California
Recruiting
Valley Village
Valley Village
California
Recruiting
Aurora
Aurora
Colorado
Recruiting
Greenwood Village
Greenwood Village
Colorado
Recruiting
Lakewood
Lakewood
Colorado
Recruiting
Washington
Washington D.C.
District of Columbia
Recruiting
Aventura
Aventura
Florida
Recruiting
Deland
DeLand
Florida
Recruiting
Hialeah
Hialeah
Florida
Recruiting
Kissimmee
Kissimmee
Florida
Recruiting
Lake Worth
Lake Worth
Florida
Recruiting
Margate
Margate
Florida
Recruiting
Miami
Miami
Florida
Recruiting
Miami
Miami
Florida
Recruiting
Miami
Miami
Florida
Recruiting
Miami Beach
Miami Beach
Florida
Recruiting
Miami Springs
Miami Springs
Florida
Recruiting
New Port Richey
New Port Richey
Florida
Recruiting
New Port Richey
New Port Richey
Florida
Recruiting
Orlando
Orlando
Florida
Recruiting
Orlando
Orlando
Florida
Recruiting
Panama City
Panama City
Florida
Recruiting
Sarasota
Sarasota
Florida
Recruiting
Tamarac
Tamarac
Florida
Recruiting
Tampa
Tampa
Florida
Recruiting
+ 80 more sites — see the full list on the official registry below.
More Sumitomo Pharma Switzerland GmbH trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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