Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05862272
Other study ID # MVT-601A-006
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date August 14, 2023
Est. completion date September 2030

Study information

Verified date March 2024
Source Sumitomo Pharma Switzerland GmbH
Contact Clinical Trials at Myovant
Phone 650-278-8743
Email ClinicalTrials@Myovant.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 with moderate-to-severe pain associated with endometriosis.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date September 2030
Est. primary completion date July 2029
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Arlington Arlington Texas
United States Atlanta Atlanta Georgia
United States Atlanta Atlanta Georgia
United States Aventura Aventura Florida
United States Bay City Bay City Michigan
United States Canoga Park Canoga Park California
United States Chandler Chandler Arizona
United States Chattanooga Chattanooga Tennessee
United States Chicago Chicago Illinois
United States Cincinnati Cincinnati Ohio
United States College Park College Park Georgia
United States Columbus Columbus Ohio
United States Columbus Columbus Ohio
United States Dallas Dallas Texas
United States Dearborn Heights Dearborn Heights Michigan
United States Deland DeLand Florida
United States Draper Draper Utah
United States Dublin Dublin Ohio
United States Durham Durham North Carolina
United States Encinitas Encinitas California
United States Englewood Englewood Ohio
United States Erie Erie Pennsylvania
United States Grand Island Grand Island Nebraska
United States Greenwood Village Greenwood Village Colorado
United States Hialeah Hialeah Florida
United States Houston Houston Texas
United States Houston Houston Texas
United States Houston Houston Texas
United States Idaho Falls Idaho Falls Idaho
United States Inglewood Inglewood California
United States Jackson Jackson Tennessee
United States Jackson Jackson Mississippi
United States Kissimmee Kissimmee Florida
United States Lake Worth Lake Worth Florida
United States Lakewood Lakewood Colorado
United States Las Vegas Las Vegas Nevada
United States League City League City Texas
United States Long Beach Long Beach California
United States Los Angeles Los Angeles California
United States Margate Margate Florida
United States Marrero Marrero Louisiana
United States Memphis Memphis Tennessee
United States Memphis Memphis Tennessee
United States Meridian Meridian Idaho
United States Mesa Mesa Arizona
United States Metairie Metairie Louisiana
United States Miami Miami Florida
United States Miami Miami Florida
United States Miami Miami Florida
United States Miami Springs Miami Springs Florida
United States Mobile Mobile Alabama
United States New Bern New Bern North Carolina
United States New Orleans New Orleans Louisiana
United States New Port Richey New Port Richey Florida
United States Newport News Newport News Virginia
United States Norcross Norcross Georgia
United States Norfolk Norfolk Nebraska
United States Norfolk Norfolk Virginia
United States North Las Vegas North Las Vegas Nevada
United States Orlando Orlando Florida
United States Palo Alto Palo Alto California
United States Panama City Panama City Florida
United States Passaic Passaic New Jersey
United States Pearland Pearland Texas
United States Philadelphia Philadelphia Pennsylvania
United States Philadelphia Philadelphia Pennsylvania
United States Phoenix Phoenix Arizona
United States Raleigh Raleigh North Carolina
United States Raleigh Raleigh North Carolina
United States Reston Reston Virginia
United States St Louis Saint Louis Missouri
United States Salt Lake City Salt Lake City Utah
United States San Antonio San Antonio Texas
United States Sarasota Sarasota Florida
United States Savannah Savannah Georgia
United States Seattle Seattle Washington
United States Shawnee Shawnee Mission Kansas
United States Slidell Slidell Louisiana
United States Smyrna Smyrna Georgia
United States Sugar Land Sugar Land Texas
United States Tamarac Tamarac Florida
United States Tampa Tampa Florida
United States Towson Towson Maryland
United States Tucson Tucson Arizona
United States Valley Village Valley Village California
United States Venice Venice Florida
United States Washington Washington District of Columbia
United States Webster Webster Texas
United States West Columbia West Columbia South Carolina
United States West Palm Beach West Palm Beach Florida
United States Wichita Wichita Kansas
United States Winston Salem Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Sumitomo Pharma Switzerland GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline up to Month 48
Primary 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. Baseline up to Month 48
Secondary 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. Baseline up to Month 48
Secondary 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. Baseline up to Month 48
Secondary 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. Baseline up to Month 6, 12, 18, 24, 30, 36, and 42
Secondary 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. Baseline up to Month 6, 12, 18, 24, 30, 36, and 42
Secondary 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. Baseline up to Month 48
Secondary 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. Baseline up to Month 48
Secondary 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. Baseline up to Month 6, 12, 18, 24, 30, 36, and 42
Secondary 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. 6 months and 12 months post treatment
Secondary 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. 6 months and 12 months post treatment
Secondary 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. 6 months and 12 months post treatment
Secondary 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. 6 months and 12 months post treatment
Secondary 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. 6 months and 12 months post treatment
Secondary 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. 6 months and 12 months post treatment
Secondary 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. Baseline up to Month 48
Secondary 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. Baseline up to Month 48 and 12 months post treatment
See also
  Status Clinical Trial Phase
Completed NCT01931670 - A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain Phase 3
Recruiting NCT05648669 - A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain Phase 3
Completed NCT04081532 - The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain N/A
Recruiting NCT06101303 - Endometriosis Pain
Completed NCT04665414 - Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI
Completed NCT03690765 - Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis
Recruiting NCT05153512 - ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream)
Active, not recruiting NCT04171297 - Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
Recruiting NCT04172272 - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures N/A
Completed NCT04565470 - Strategies of Self-management of Endometriosis Symptoms
Completed NCT03613298 - Treatment by HIFU With Focal One® of Posterior Deep Infiltrating Endometriosis Lesions With Intestinal Involvement. N/A
Withdrawn NCT05568940 - Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
Not yet recruiting NCT03464799 - Does Immunotherapy Have a Role in the Management of Endometriosis?
Active, not recruiting NCT03002870 - Characteristics of Patient Population With Endometriosis N/A
Completed NCT02973854 - Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat
Withdrawn NCT03272360 - Endometriosis Biomarker Discovery Study N/A
Recruiting NCT02481739 - Laparoscopic Surgical Management of Endometriosis on Fertility N/A
Active, not recruiting NCT02754648 - Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve N/A
Completed NCT06106932 - GnRH-a on Angiogenesis of Endometriosis N/A
Completed NCT02387931 - Supplementation in Adolescent Girls With Endometriosis Phase 4