Actively 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
Led by Sumitomo Pharma Switzerland GmbH · Updated on 2025-08-06
1000
Participants Needed
120
Research Sites
367 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Premenopausal women aged 18 to 50 years inclusive
- Diagnosed with uterine fibroids confirmed by imaging or medical records and experiencing heavy menstrual bleeding affecting quality of life, or diagnosed with endometriosis causing moderate to severe pain
- Willing to avoid pregnancy for 4 years during treatment using nonhormonal contraception if at risk of pregnancy
- Negative serum pregnancy test at screening and negative urine pregnancy test at allocation or Month 12 if entering from prior study
- In good physical and mental health based on medical history, examinations, lab tests, and vital signs
- Body mass index of at least 18 kg/m2
You will not qualify if you...
- Body size or condition that prevents accurate DXA bone density measurement at lumbar spine or hip
- DXA results showing Z-score ≤ -1.5 or T-score ≤ -2.0 (if 40 years or older) for new participants, or more severe bone loss if entering from prior study
- Vitamin D level below 12 ng/mL (supplementation allowed if levels 12 to <20 ng/mL)
- History or current diagnosis of Cushing's Syndrome, rheumatoid arthritis, metabolic bone disease, uncorrected hyperparathyroidism, Paget's disease, collagen vascular disease, Marfan's syndrome, Ehlers-Danlos syndrome, chronic kidney disease stage 3 or worse, hyperprolactinemia, pituitary adenoma, hyperthyroidism, anorexia nervosa, bulimia within the past year, or abnormal bone mineral metabolism
- History of low trauma fracture
- Use of bone loss medications other than calcium or vitamin D
- Prior use of depot-medroxyprogesterone acetate over 2 years within past 5 years or GnRH agonist/antagonist over 12 months unless from prior study
- Malabsorptive diseases including inflammatory bowel disease or gastric bypass surgery
- Current or history of breast cancer or other hormone-sensitive cancers, or use of aromatase inhibitors
- History of organ or bone marrow transplant
- Mammogram with BIRADS ≥ 3 within past 6 months
- Known HIV infection or high risk for HIV
- Current psychiatric disorder impairing participation or data interpretation
- Current use of prohibited hormonal contraception and unwillingness to discontinue it
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 120 locations
1
Mobile
Mobile, Alabama, United States, 36604
Actively Recruiting
2
Chandler
Chandler, Arizona, United States, 85224
Actively Recruiting
3
Mesa
Mesa, Arizona, United States, 85209
Actively Recruiting
4
Peoria
Peoria, Arizona, United States, 85381
Actively Recruiting
5
Phoenix
Phoenix, Arizona, United States, 85018
Actively Recruiting
6
Tucson
Tucson, Arizona, United States, 85715-3834
Actively Recruiting
7
Burbank
Burbank, California, United States, 91506-1773
Actively Recruiting
8
Canoga Park
Canoga Park, California, United States, 91303
Actively Recruiting
9
Encinitas
Encinitas, California, United States, 92024-1329
Actively Recruiting
10
Inglewood
Inglewood, California, United States, 90301
Actively Recruiting
11
Lomita
Lomita, California, United States, 90717-2101
Actively Recruiting
12
Long Beach
Long Beach, California, United States, 90805-4587
Actively Recruiting
13
Los Angeles
Los Angeles, California, United States, 90036
Actively Recruiting
14
Sacramento
Sacramento, California, United States, 95817-2307
Actively Recruiting
15
San Fernando
San Fernando, California, United States, 91340-4199
Actively Recruiting
16
Stanford
Stanford, California, United States, 94305-2200
Actively Recruiting
17
Valley Village
Valley Village, California, United States, 91607
Actively Recruiting
18
Aurora
Aurora, Colorado, United States, 80045-2517
Actively Recruiting
19
Greenwood Village
Greenwood Village, Colorado, United States, 80111
Actively Recruiting
20
Lakewood
Lakewood, Colorado, United States, 80228
Actively Recruiting
21
Washington
Washington D.C., District of Columbia, United States, 02011
Actively Recruiting
22
Aventura
Aventura, Florida, United States, 33180
Actively Recruiting
23
Deland
DeLand, Florida, United States, 32720
Actively Recruiting
24
Hialeah
Hialeah, Florida, United States, 33016
Actively Recruiting
25
Kissimmee
Kissimmee, Florida, United States, 34741-2358
Actively Recruiting
26
Lake Worth
Lake Worth, Florida, United States, 33461
Actively Recruiting
27
Margate
Margate, Florida, United States, 33063-5715
Actively Recruiting
28
Miami
Miami, Florida, United States, 33126
Actively Recruiting
29
Miami
Miami, Florida, United States, 33155
Actively Recruiting
30
Miami
Miami, Florida, United States, 33173
Actively Recruiting
31
Miami Beach
Miami Beach, Florida, United States, 33140
Actively Recruiting
32
Miami Springs
Miami Springs, Florida, United States, 33166
Actively Recruiting
33
New Port Richey
New Port Richey, Florida, United States, 34652-4020
Actively Recruiting
34
New Port Richey
New Port Richey, Florida, United States, 34652
Actively Recruiting
35
Orlando
Orlando, Florida, United States, 32808
Actively Recruiting
36
Orlando
Orlando, Florida, United States, 32819
Actively Recruiting
37
Panama City
Panama City, Florida, United States, 32405
Actively Recruiting
38
Sarasota
Sarasota, Florida, United States, 34239
Actively Recruiting
39
Tamarac
Tamarac, Florida, United States, 33321
Actively Recruiting
40
Tampa
Tampa, Florida, United States, 33614-1874
Actively Recruiting
41
Venice
Venice, Florida, United States, 34285
Actively Recruiting
42
West Palm Beach
West Palm Beach, Florida, United States, 33409
Actively Recruiting
43
Atlanta
Atlanta, Georgia, United States, 30342
Actively Recruiting
44
Atlanta
Atlanta, Georgia, United States, 30363
Actively Recruiting
45
College Park
College Park, Georgia, United States, 30349-3103
Actively Recruiting
46
Fayetteville
Fayetteville, Georgia, United States, 31204
Actively Recruiting
47
Norcross
Norcross, Georgia, United States, 30093
Actively Recruiting
48
Idaho Falls
Idaho Falls, Idaho, United States, 83404-8322
Actively Recruiting
49
Idaho Falls
Idaho Falls, Idaho, United States, 83404
Actively Recruiting
50
Meridian
Meridian, Idaho, United States, 83646
Actively Recruiting
51
Chicago
Chicago, Illinois, United States, 60607-4911
Actively Recruiting
52
Chicago
Chicago, Illinois, United States, 60616
Actively Recruiting
53
Schaumburg
Schaumburg, Illinois, United States, 60173-5831
Actively Recruiting
54
Lenexa
Lenexa, Kansas, United States, 66215-2733
Actively Recruiting
55
Wichita
Wichita, Kansas, United States, 67211
Actively Recruiting
56
Covington
Covington, Louisiana, United States, 70433
Actively Recruiting
57
Marrero
Marrero, Louisiana, United States, 70072
Actively Recruiting
58
Metairie
Metairie, Louisiana, United States, 70001
Actively Recruiting
59
New Orleans
New Orleans, Louisiana, United States, 70115-6235
Actively Recruiting
60
New Orleans
New Orleans, Louisiana, United States, 70127
Actively Recruiting
61
Slidell
Slidell, Louisiana, United States, 70458-2004
Actively Recruiting
62
Baltimore
Baltimore, Maryland, United States, 21205
Actively Recruiting
63
Laurel
Laurel, Maryland, United States, 20707-5203
Actively Recruiting
64
Towson
Towson, Maryland, United States, 21204
Actively Recruiting
65
Bay City
Bay City, Michigan, United States, 48706
Actively Recruiting
66
Dearborn Heights
Dearborn Heights, Michigan, United States, 48127
Actively Recruiting
67
Detroit
Detroit, Michigan, United States, 48201
Actively Recruiting
68
Ridgeland
Ridgeland, Mississippi, United States, 39157-5179
Actively Recruiting
69
Saint Louis
St Louis, Missouri, United States, 63108-1495
Actively Recruiting
70
St Louis
St Louis, Missouri, United States, 63141
Actively Recruiting
71
Grand Island
Grand Island, Nebraska, United States, 68803-4327
Actively Recruiting
72
Norfolk
Norfolk, Nebraska, United States, 68701
Actively Recruiting
73
Las Vegas
Las Vegas, Nevada, United States, 89109
Actively Recruiting
74
North Las Vegas
North Las Vegas, Nevada, United States, 89030
Actively Recruiting
75
West New York
West New York, New Jersey, United States, 07093-2622
Actively Recruiting
76
Durham
Durham, North Carolina, United States, 27713
Actively Recruiting
77
New Bern
New Bern, North Carolina, United States, 28562
Actively Recruiting
78
Raleigh
Raleigh, North Carolina, United States, 27607
Actively Recruiting
79
Raleigh
Raleigh, North Carolina, United States, 27612-8104
Actively Recruiting
80
Winston Salem
Winston-Salem, North Carolina, United States, 27103-1749
Actively Recruiting
81
Cincinnati
Cincinnati, Ohio, United States, 45255
Actively Recruiting
82
Cleveland
Cleveland, Ohio, United States, 44124
Actively Recruiting
83
Columbus
Columbus, Ohio, United States, 43213
Actively Recruiting
84
Columbus
Columbus, Ohio, United States, 43231
Actively Recruiting
85
Dublin
Dublin, Ohio, United States, 43016
Actively Recruiting
86
Englewood
Englewood, Ohio, United States, 45322
Actively Recruiting
87
Middletown
Middletown, Ohio, United States, 45005-2593
Actively Recruiting
88
Erie
Erie, Pennsylvania, United States, 16507-1423
Actively Recruiting
89
Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
90
Philadelphia
Philadelphia, Pennsylvania, United States, 19114
Actively Recruiting
91
Bluffton
Bluffton, South Carolina, United States, 29910-4883
Actively Recruiting
92
Greenville
Greenville, South Carolina, United States, 29615-4833
Actively Recruiting
93
Summerville
Summerville, South Carolina, United States, 29485-8345
Actively Recruiting
94
West Columbia
West Columbia, South Carolina, United States, 29169
Actively Recruiting
95
Chattanooga
Chattanooga, Tennessee, United States, 37404
Actively Recruiting
96
Jackson
Jackson, Tennessee, United States, 38305
Actively Recruiting
97
Memphis
Memphis, Tennessee, United States, 38119
Actively Recruiting
98
Memphis
Memphis, Tennessee, United States, 38120
Actively Recruiting
99
Arlington
Arlington, Texas, United States, 76012-4705
Actively Recruiting
100
Dallas
Dallas, Texas, United States, 75230-2598
Actively Recruiting
101
Dallas
Dallas, Texas, United States, 75230
Actively Recruiting
102
Fort Worth
Fort Worth, Texas, United States, 76104-4141
Actively Recruiting
103
Galveston
Galveston, Texas, United States, 77555
Actively Recruiting
104
Houston
Houston, Texas, United States, 77021
Actively Recruiting
105
Houston
Houston, Texas, United States, 77024
Actively Recruiting
106
Houston
Houston, Texas, United States, 77030-4514
Actively Recruiting
107
Houston
Houston, Texas, United States, 77054
Actively Recruiting
108
League City
League City, Texas, United States, 77573
Actively Recruiting
109
Pearland
Pearland, Texas, United States, 77584
Actively Recruiting
110
San Antonio
San Antonio, Texas, United States, 78230
Actively Recruiting
111
San Antonio
San Antonio, Texas, United States, 78258
Actively Recruiting
112
Sugar Land
Sugar Land, Texas, United States, 77479-1001
Actively Recruiting
113
Sugar Land
Sugar Land, Texas, United States, 77479
Actively Recruiting
114
Webster
Webster, Texas, United States, 77598-4081
Actively Recruiting
115
Pleasant Grove
Pleasant Grove, Utah, United States, 84062-4097
Actively Recruiting
116
Salt Lake City
Salt Lake City, Utah, United States, 84107
Actively Recruiting
117
Annandale
Annandale, Virginia, United States, 22003-7308
Actively Recruiting
118
Newport News
Newport News, Virginia, United States, 23606
Actively Recruiting
119
Virginia Beach
Virginia Beach, Virginia, United States, 23456-8125
Actively Recruiting
120
Seattle
Seattle, Washington, United States, 98105-4028
Actively Recruiting
Research Team
C
Clinical Trials at Myovant
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here