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A Phase 3B, Single-Arm, Open-Label Study to Evaluate Bone Mineral Density with Long-Term Use of Relugolix Combination Tablet in Premenopausal Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids or Moderate to Severe Pain Associated with Endometriosis

To follow changes in bone mineral density (BMD) over time when Myfembree is used for up to 4 years. Also to follow BMD for 1 year after treatment is stopped.


Why this Research Matters

Currently, this medicine is approved by the United States (US) Food and Drug Administration (FDA) for up to 2 years of use for the management of premenopausal women with moderate to severe pain associated with endometriosis. The sponsor is investigating if this medication can be taken for 4 years. This study looks at the medication's effect on bone (BMD) and your body over the four years of treatment and for one year after treatment stops.


Who can Participate

Adult

-Premenopausal women 18-50 years with a diagnosis of endometriosis -Premenopausal women 18-50 years with a diagnosis of endometriosis -Not pregnant and willing to avoid pregnancy for 4 years -has a BMI greater than 18 kg/m2 -have a Vitamin D level higher than 12ng/mL -No history of low trama facture -No history of gastric surgery -Normal mammogram -No current breast cancer


Study ID

Protocol Number: 24-0067

Meet the Team

Image of Principal Investigator

Jill Liss, MD

Principal Investigator