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
Research Team
C
Clinical Trials at Myovant
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