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

• Status: Not yet recruiting
• Trial end date: 2030-08-01
• Target enrollment: 0
• Participant gender: Female

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 with moderate-to-severe pain associated with endometriosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Myovant Sciences GmbH
• Treatments: Relugolix

Criteria

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 (

• 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, abnormal bone mineral metabolism, , Paget's disease of the bone, collagen vascular disease, Marfan's syndrome, Ehlers-Danlos syndrome, chronic kidney disease (CKD) stage 3 or greater (or glomerular filtration rate (GFR) < 60 mL/min/m2 using Modification of Diet in Renal Disease (MDRD) method), uncorrected hyperparathyroidism, hyperprolactinemia, known pituitary adenoma, hyperthyroidism, anorexia nervosa, bulimia (within the last year),

• 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);

• Has breast cancer or history of breast cancer

• 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.