A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis

Cannot have received: medication used to treat bone loss (other than calcium and vitamin D)

Past history of use or current use of medication used to treat bone loss other than calcium and vitamin D preparations

Cannot have received: depot-medroxyprogesterone acetate

Exception: if treatment occurred within the past 5 years and duration > 2 years

Prior use of depot-medroxyprogesterone acetate for a treatment period > 2 years (if treatment occurred within the past 5 years)

Cannot have received: GnRH agonist or antagonist

Exception: unless directly entering from MVT-601-050 [NCT04756037; SERENE]; prior use > 12 months total

prior use of GnRH agonist or antagonist for > 12 months total (unless directly entering from MVT-601-050 [NCT04756037; SERENE])

Cannot have received: hormonal intrauterine device or contraceptive implant, hormonal contraceptive, or other prohibited medication

Exception: unless willing to discontinue

currently using a hormonal intrauterine device or contraceptive implant, hormonal contraceptive, or other prohibited medication and is unwilling to discontinue this hormonal contraception

Cannot have received: aromatase inhibitor

taking an aromatase inhibitor for breast cancer treatment or prevention