Trial Title:
A Phase 3B Study to Evaluate Bone Mineral Density with Long-Term Use of Relugolix Combination Tablet in Women with Uterine Fibroids or Endometriosis
NCT ID:
NCT05862272
Condition:
Uterine Fibroids
Endometriosis
Conditions: Official terms:
Leiomyoma
Myofibroma
Endometriosis
Relugolix
Conditions: Keywords:
Uterine Leiomyomas
Fibroids
Endometriosis
Bone Mineral Density
Relugolix
Estradiol
Norethindrone acetate
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Relugolix Combination Tablet
Description:
A fixed-dose combination tablet containing relugolix 40 mg, estradiol (E2) 1 mg, and
norethindrone acetate (NETA) 0.5 mg.
Arm group label:
Relugolix Combination Tablet
Other name:
TAK-385
Other name:
T-1331285
Other name:
RVT-601
Other name:
MVT-601
Other name:
MVT-601A
Other name:
MYFEMBREE
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.
Detailed 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.
Criteria for eligibility:
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 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
50 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Mobile
Address:
City:
Mobile
Zip:
36604
Country:
United States
Status:
Recruiting
Facility:
Name:
Chandler
Address:
City:
Chandler
Zip:
85224
Country:
United States
Status:
Recruiting
Facility:
Name:
Mesa
Address:
City:
Mesa
Zip:
85209
Country:
United States
Status:
Recruiting
Facility:
Name:
Phoenix
Address:
City:
Phoenix
Zip:
85018
Country:
United States
Status:
Recruiting
Facility:
Name:
Tucson
Address:
City:
Tucson
Zip:
85715-3834
Country:
United States
Status:
Recruiting
Facility:
Name:
Canoga Park
Address:
City:
Canoga Park
Zip:
91303
Country:
United States
Status:
Recruiting
Facility:
Name:
Encinitas
Address:
City:
Encinitas
Zip:
92024-1329
Country:
United States
Status:
Recruiting
Facility:
Name:
Inglewood
Address:
City:
Inglewood
Zip:
90301
Country:
United States
Status:
Recruiting
Facility:
Name:
Long Beach
Address:
City:
Long Beach
Zip:
90805-4587
Country:
United States
Status:
Recruiting
Facility:
Name:
Los Angeles
Address:
City:
Los Angeles
Zip:
90036
Country:
United States
Status:
Recruiting
Facility:
Name:
Palo Alto
Address:
City:
Palo Alto
Zip:
94304
Country:
United States
Status:
Recruiting
Facility:
Name:
Valley Village
Address:
City:
Valley Village
Zip:
91607
Country:
United States
Status:
Recruiting
Facility:
Name:
Greenwood Village
Address:
City:
Greenwood Village
Zip:
80111
Country:
United States
Status:
Recruiting
Facility:
Name:
Lakewood
Address:
City:
Lakewood
Zip:
80228
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington
Address:
City:
Washington
Zip:
02011
Country:
United States
Status:
Recruiting
Facility:
Name:
Aventura
Address:
City:
Aventura
Zip:
33180
Country:
United States
Status:
Recruiting
Facility:
Name:
Deland
Address:
City:
Deland
Zip:
32720
Country:
United States
Status:
Recruiting
Facility:
Name:
Hialeah
Address:
City:
Hialeah
Zip:
33016
Country:
United States
Status:
Recruiting
Facility:
Name:
Kissimmee
Address:
City:
Kissimmee
Zip:
34741-2358
Country:
United States
Status:
Recruiting
Facility:
Name:
Lake Worth
Address:
City:
Lake Worth
Zip:
33461
Country:
United States
Status:
Recruiting
Facility:
Name:
Margate
Address:
City:
Margate
Zip:
33063-5715
Country:
United States
Status:
Recruiting
Facility:
Name:
Miami Springs
Address:
City:
Miami Springs
Zip:
33166
Country:
United States
Status:
Recruiting
Facility:
Name:
Miami
Address:
City:
Miami
Zip:
33126
Country:
United States
Status:
Recruiting
Facility:
Name:
Miami
Address:
City:
Miami
Zip:
33155
Country:
United States
Status:
Recruiting
Facility:
Name:
Miami
Address:
City:
Miami
Zip:
33173
Country:
United States
Status:
Recruiting
Facility:
Name:
New Port Richey
Address:
City:
New Port Richey
Zip:
34652
Country:
United States
Status:
Recruiting
Facility:
Name:
Orlando
Address:
City:
Orlando
Zip:
32819
Country:
United States
Status:
Recruiting
Facility:
Name:
Panama City
Address:
City:
Panama City
Zip:
32405
Country:
United States
Status:
Recruiting
Facility:
Name:
Sarasota
Address:
City:
Sarasota
Zip:
34239
Country:
United States
Status:
Recruiting
Facility:
Name:
Tamarac
Address:
City:
Tamarac
Zip:
33321
Country:
United States
Status:
Recruiting
Facility:
Name:
Tampa
Address:
City:
Tampa
Zip:
33614-1874
Country:
United States
Status:
Recruiting
Facility:
Name:
Venice
Address:
City:
Venice
Zip:
34285
Country:
United States
Status:
Recruiting
Facility:
Name:
West Palm Beach
Address:
City:
West Palm Beach
Zip:
33409
Country:
United States
Status:
Recruiting
Facility:
Name:
Atlanta
Address:
City:
Atlanta
Zip:
30342
Country:
United States
Status:
Recruiting
Facility:
Name:
Atlanta
Address:
City:
Atlanta
Zip:
30363
Country:
United States
Status:
Recruiting
Facility:
Name:
College Park
Address:
City:
College Park
Zip:
30349-3103
Country:
United States
Status:
Recruiting
Facility:
Name:
Norcross
Address:
City:
Norcross
Zip:
30093
Country:
United States
Status:
Recruiting
Facility:
Name:
Savannah
Address:
City:
Savannah
Zip:
31406
Country:
United States
Status:
Recruiting
Facility:
Name:
Smyrna
Address:
City:
Smyrna
Zip:
30082
Country:
United States
Status:
Recruiting
Facility:
Name:
Idaho Falls
Address:
City:
Idaho Falls
Zip:
83404
Country:
United States
Status:
Recruiting
Facility:
Name:
Meridian
Address:
City:
Meridian
Zip:
83646
Country:
United States
Status:
Recruiting
Facility:
Name:
Chicago
Address:
City:
Chicago
Zip:
60616
Country:
United States
Status:
Recruiting
Facility:
Name:
Shawnee
Address:
City:
Shawnee
Zip:
66218
Country:
United States
Status:
Recruiting
Facility:
Name:
Wichita
Address:
City:
Wichita
Zip:
67211
Country:
United States
Status:
Recruiting
Facility:
Name:
Marrero
Address:
City:
Marrero
Zip:
70072
Country:
United States
Status:
Recruiting
Facility:
Name:
Metairie
Address:
City:
Metairie
Zip:
70001
Country:
United States
Status:
Recruiting
Facility:
Name:
New Orleans
Address:
City:
New Orleans
Zip:
70127
Country:
United States
Status:
Recruiting
Facility:
Name:
Slidell
Address:
City:
Slidell
Zip:
70458-2004
Country:
United States
Status:
Recruiting
Facility:
Name:
Towson
Address:
City:
Towson
Zip:
21204
Country:
United States
Status:
Recruiting
Facility:
Name:
Bay City
Address:
City:
Bay City
Zip:
48706
Country:
United States
Status:
Recruiting
Facility:
Name:
Dearborn Heights
Address:
City:
Dearborn Heights
Zip:
48127
Country:
United States
Status:
Recruiting
Facility:
Name:
Jackson
Address:
City:
Jackson
Zip:
39202
Country:
United States
Status:
Recruiting
Facility:
Name:
St Louis
Address:
City:
St Louis
Zip:
63141
Country:
United States
Status:
Recruiting
Facility:
Name:
Grand Island
Address:
City:
Grand Island
Zip:
68803-4327
Country:
United States
Status:
Recruiting
Facility:
Name:
Norfolk
Address:
City:
Norfolk
Zip:
68701
Country:
United States
Status:
Recruiting
Facility:
Name:
Las Vegas
Address:
City:
Las Vegas
Zip:
89109
Country:
United States
Status:
Recruiting
Facility:
Name:
North Las Vegas
Address:
City:
North Las Vegas
Zip:
89030
Country:
United States
Status:
Recruiting
Facility:
Name:
Passaic
Address:
City:
Passaic
Zip:
07055
Country:
United States
Status:
Recruiting
Facility:
Name:
Durham
Address:
City:
Durham
Zip:
27713
Country:
United States
Status:
Recruiting
Facility:
Name:
New Bern
Address:
City:
New Bern
Zip:
28562
Country:
United States
Status:
Recruiting
Facility:
Name:
Raleigh
Address:
City:
Raleigh
Zip:
27607
Country:
United States
Status:
Recruiting
Facility:
Name:
Raleigh
Address:
City:
Raleigh
Zip:
27612-8104
Country:
United States
Status:
Recruiting
Facility:
Name:
Winston Salem
Address:
City:
Winston Salem
Zip:
27103-1749
Country:
United States
Status:
Recruiting
Facility:
Name:
Cincinnati
Address:
City:
Cincinnati
Zip:
45255
Country:
United States
Status:
Recruiting
Facility:
Name:
Cleveland
Address:
City:
Cleveland
Zip:
44124
Country:
United States
Status:
Recruiting
Facility:
Name:
Columbus
Address:
City:
Columbus
Zip:
43213
Country:
United States
Status:
Recruiting
Facility:
Name:
Columbus
Address:
City:
Columbus
Zip:
43231
Country:
United States
Status:
Recruiting
Facility:
Name:
Dublin
Address:
City:
Dublin
Zip:
43016
Country:
United States
Status:
Recruiting
Facility:
Name:
Englewood
Address:
City:
Englewood
Zip:
45322
Country:
United States
Status:
Recruiting
Facility:
Name:
Erie
Address:
City:
Erie
Zip:
16507-1423
Country:
United States
Status:
Recruiting
Facility:
Name:
Philadelphia
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Facility:
Name:
Philadelphia
Address:
City:
Philadelphia
Zip:
19114
Country:
United States
Status:
Recruiting
Facility:
Name:
West Columbia
Address:
City:
West Columbia
Zip:
29169
Country:
United States
Status:
Recruiting
Facility:
Name:
Chattanooga
Address:
City:
Chattanooga
Zip:
37404
Country:
United States
Status:
Recruiting
Facility:
Name:
Jackson
Address:
City:
Jackson
Zip:
38305
Country:
United States
Status:
Recruiting
Facility:
Name:
Memphis
Address:
City:
Memphis
Zip:
38119
Country:
United States
Status:
Recruiting
Facility:
Name:
Memphis
Address:
City:
Memphis
Zip:
38120
Country:
United States
Status:
Recruiting
Facility:
Name:
Arlington
Address:
City:
Arlington
Zip:
76012-4705
Country:
United States
Status:
Recruiting
Facility:
Name:
Dallas
Address:
City:
Dallas
Zip:
75230
Country:
United States
Status:
Recruiting
Facility:
Name:
Houston
Address:
City:
Houston
Zip:
77021
Country:
United States
Status:
Recruiting
Facility:
Name:
Houston
Address:
City:
Houston
Zip:
77024
Country:
United States
Status:
Recruiting
Facility:
Name:
Houston
Address:
City:
Houston
Zip:
77054
Country:
United States
Status:
Recruiting
Facility:
Name:
League City
Address:
City:
League City
Zip:
77573
Country:
United States
Status:
Recruiting
Facility:
Name:
Pearland
Address:
City:
Pearland
Zip:
77584
Country:
United States
Status:
Recruiting
Facility:
Name:
San Antonio
Address:
City:
San Antonio
Zip:
78258
Country:
United States
Status:
Recruiting
Facility:
Name:
Sugar Land
Address:
City:
Sugar Land
Zip:
77479
Country:
United States
Status:
Recruiting
Facility:
Name:
Webster
Address:
City:
Webster
Zip:
77598-4081
Country:
United States
Status:
Recruiting
Facility:
Name:
Draper
Address:
City:
Draper
Zip:
84020
Country:
United States
Status:
Recruiting
Facility:
Name:
Salt Lake City
Address:
City:
Salt Lake City
Zip:
84107
Country:
United States
Status:
Recruiting
Facility:
Name:
Newport News
Address:
City:
Newport News
Zip:
23606
Country:
United States
Status:
Recruiting
Facility:
Name:
Norfolk
Address:
City:
Norfolk
Zip:
23502
Country:
United States
Status:
Recruiting
Facility:
Name:
Reston
Address:
City:
Reston
Zip:
22003
Country:
United States
Status:
Recruiting
Facility:
Name:
Seattle
Address:
City:
Seattle
Zip:
98105-4028
Country:
United States
Status:
Recruiting
Start date:
August 14, 2023
Completion date:
September 2030
Lead sponsor:
Agency:
Sumitomo Pharma Switzerland GmbH
Agency class:
Industry
Source:
Sumitomo Pharma Switzerland GmbH
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05862272
