Actively Recruiting
A Phase 3B, Single-Arm Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Premenopausal Women With Uterine Fibroids or Endometriosis
Led by Sumitomo Pharma Switzerland GmbH · Updated on 2025-08-06
1000
Participants Needed
120
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating changes in bone mineral density in premenopausal women with heavy menstrual bleeding caused by uterine fibroids or moderate-to-severe pain from endometriosis. This Phase 3B, open-label study looks at the effects of continuous treatment with a relugolix combination tablet for up to 48 months (4 years), followed by a 1-year period to monitor bone health after stopping treatment. Participants will take a daily oral relugolix combination tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg for 4 years. Bone mineral density will be measured every 6 months using dual-energy X-ray absorptiometry (DXA). Some women who have completed a previous related study may join to complete 3 years of treatment. After treatment ends, bone density will be checked again at 6 months and 12 months during the follow-up year. Women in the study will have regular visits for bone density scans and health assessments, including physical and gynecological exams, lab tests, and vital signs. Researchers will track changes in bone density at the spine, hip, and femoral neck throughout treatment and follow-up. They will also monitor for any fractures or adverse events during the 4 years of treatment and the 1-year post-treatment period. Total participation can last up to 5 years including the follow-up.
CONDITIONS
Brief 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)
- Diagnosis of uterine fibroids confirmed by imaging or medical records with heavy menstrual bleeding impacting quality of life, or diagnosis of endometriosis with moderate to severe pain
- Willingness to avoid pregnancy for 4 years using nonhormonal contraception if at risk of pregnancy
- Negative serum pregnancy test at screening and negative urine pregnancy test at allocation
- Good physical and mental health based on medical history, physical, gynecological and breast exams, lab tests, and vital signs
- Body mass index of 18 kg/m² or higher
You will not qualify if you...
- Weight or body type exceeding DXA scanner limits or conditions preventing adequate DXA measurement at lumbar spine or femur
- DXA results showing low bone density scores (Z-score ≤ -1.5 or T-score ≤ -2.0 if ≥ 40 years) or significant bone loss if entering from prior study
- Vitamin D deficiency with 25-OH vitamin D level below 12 ng/mL (unless supplementing appropriately)
- History or presence of certain bone diseases, metabolic or hormonal disorders, severe kidney disease, or psychiatric conditions impacting participation
- History of low trauma fractures
- Use of bone loss treatments other than calcium or vitamin D supplements
- Prior long-term use of certain hormonal therapies exceeding specified durations
- Malabsorptive diseases like inflammatory bowel disease or gastric bypass surgery
- Current or history of hormone-sensitive cancers or taking related treatments
- History of organ or bone marrow transplant
- Recent mammogram showing suspicious findings (BIRADS ≥ 3)
- Known HIV infection or high risk for HIV
- Current psychiatric disorder affecting study participation or data interpretation
- Current use of hormonal contraceptives or unwillingness to discontinue prohibited hormonal contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 months (4 years)
Participants take the relugolix combination tablet orally once daily while bone mineral density is assessed every 6 months.
Visits every 6 months for bone mineral density assessments
Duration - 12 months
After treatment ends, participants are followed for 1 year to monitor bone mineral density.
2 visits at 6 and 12 months post-treatment
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
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8
Canoga Park
Canoga Park, California, United States, 91303
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9
Encinitas
Encinitas, California, United States, 92024-1329
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10
Inglewood
Inglewood, California, United States, 90301
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11
Lomita
Lomita, California, United States, 90717-2101
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12
Long Beach
Long Beach, California, United States, 90805-4587
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13
Los Angeles
Los Angeles, California, United States, 90036
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14
Sacramento
Sacramento, California, United States, 95817-2307
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15
San Fernando
San Fernando, California, United States, 91340-4199
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16
Stanford
Stanford, California, United States, 94305-2200
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17
Valley Village
Valley Village, California, United States, 91607
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18
Aurora
Aurora, Colorado, United States, 80045-2517
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19
Greenwood Village
Greenwood Village, Colorado, United States, 80111
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20
Lakewood
Lakewood, Colorado, United States, 80228
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21
Washington
Washington D.C., District of Columbia, United States, 02011
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22
Aventura
Aventura, Florida, United States, 33180
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23
Deland
DeLand, Florida, United States, 32720
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24
Hialeah
Hialeah, Florida, United States, 33016
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25
Kissimmee
Kissimmee, Florida, United States, 34741-2358
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26
Lake Worth
Lake Worth, Florida, United States, 33461
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27
Margate
Margate, Florida, United States, 33063-5715
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28
Miami
Miami, Florida, United States, 33126
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29
Miami
Miami, Florida, United States, 33155
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30
Miami
Miami, Florida, United States, 33173
Actively Recruiting
31
Miami Beach
Miami Beach, Florida, United States, 33140
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32
Miami Springs
Miami Springs, Florida, United States, 33166
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33
New Port Richey
New Port Richey, Florida, United States, 34652-4020
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34
New Port Richey
New Port Richey, Florida, United States, 34652
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35
Orlando
Orlando, Florida, United States, 32808
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36
Orlando
Orlando, Florida, United States, 32819
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37
Panama City
Panama City, Florida, United States, 32405
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38
Sarasota
Sarasota, Florida, United States, 34239
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39
Tamarac
Tamarac, Florida, United States, 33321
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40
Tampa
Tampa, Florida, United States, 33614-1874
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41
Venice
Venice, Florida, United States, 34285
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42
West Palm Beach
West Palm Beach, Florida, United States, 33409
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43
Atlanta
Atlanta, Georgia, United States, 30342
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44
Atlanta
Atlanta, Georgia, United States, 30363
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45
College Park
College Park, Georgia, United States, 30349-3103
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46
Fayetteville
Fayetteville, Georgia, United States, 31204
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47
Norcross
Norcross, Georgia, United States, 30093
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48
Idaho Falls
Idaho Falls, Idaho, United States, 83404-8322
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49
Idaho Falls
Idaho Falls, Idaho, United States, 83404
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50
Meridian
Meridian, Idaho, United States, 83646
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51
Chicago
Chicago, Illinois, United States, 60607-4911
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52
Chicago
Chicago, Illinois, United States, 60616
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53
Schaumburg
Schaumburg, Illinois, United States, 60173-5831
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54
Lenexa
Lenexa, Kansas, United States, 66215-2733
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55
Wichita
Wichita, Kansas, United States, 67211
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56
Covington
Covington, Louisiana, United States, 70433
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57
Marrero
Marrero, Louisiana, United States, 70072
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58
Metairie
Metairie, Louisiana, United States, 70001
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59
New Orleans
New Orleans, Louisiana, United States, 70115-6235
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60
New Orleans
New Orleans, Louisiana, United States, 70127
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61
Slidell
Slidell, Louisiana, United States, 70458-2004
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62
Baltimore
Baltimore, Maryland, United States, 21205
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63
Laurel
Laurel, Maryland, United States, 20707-5203
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64
Towson
Towson, Maryland, United States, 21204
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65
Bay City
Bay City, Michigan, United States, 48706
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66
Dearborn Heights
Dearborn Heights, Michigan, United States, 48127
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67
Detroit
Detroit, Michigan, United States, 48201
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68
Ridgeland
Ridgeland, Mississippi, United States, 39157-5179
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69
Saint Louis
St Louis, Missouri, United States, 63108-1495
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70
St Louis
St Louis, Missouri, United States, 63141
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71
Grand Island
Grand Island, Nebraska, United States, 68803-4327
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72
Norfolk
Norfolk, Nebraska, United States, 68701
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73
Las Vegas
Las Vegas, Nevada, United States, 89109
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74
North Las Vegas
North Las Vegas, Nevada, United States, 89030
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75
West New York
West New York, New Jersey, United States, 07093-2622
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76
Durham
Durham, North Carolina, United States, 27713
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77
New Bern
New Bern, North Carolina, United States, 28562
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78
Raleigh
Raleigh, North Carolina, United States, 27607
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79
Raleigh
Raleigh, North Carolina, United States, 27612-8104
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80
Winston Salem
Winston-Salem, North Carolina, United States, 27103-1749
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81
Cincinnati
Cincinnati, Ohio, United States, 45255
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82
Cleveland
Cleveland, Ohio, United States, 44124
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83
Columbus
Columbus, Ohio, United States, 43213
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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
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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
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93
Summerville
Summerville, South Carolina, United States, 29485-8345
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94
West Columbia
West Columbia, South Carolina, United States, 29169
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95
Chattanooga
Chattanooga, Tennessee, United States, 37404
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96
Jackson
Jackson, Tennessee, United States, 38305
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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
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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
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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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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