A Phase 3B Trial to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis
Phase 3
1,000
about 7.1 years
18–50
Female only
120 sites in AL, AZ, CA +24
What this study is about
Researchers are testing the effect of relugolix combination tablets on bone mineral density over a long period (up to 4 years) in women with uterine fibroids or endometriosis. The trial will last for approximately 2604 days and involve around 1000 participants.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Relugolix Combination Tablet
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
relugolix
oral (Oral Tablet), oral
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., Percent change from baseline in BMD at Month 48 on-treatment at lumbar spine (L1-L4) in women with endometriosis.
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., Percent change from baseline in BMD at Month 48 on-treatment at lumbar spine (L1-L4) in the overall study population., Percent change from baseline in BMD at Month 48 on-treatment at total hip and femoral neck in the overall study population., Percent change from baseline in BMD at Month 48 on-treatment at total hip and femoral neck in women with endometriosis., Percent change from baseline in BMD at Month 48 on-treatment at total hip and femoral neck in women with uterine fibroids., 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., 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., 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.
Reproductive Health