Protocol Title: 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
Short 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
INCLUSION CRITERIA:
A patient is eligible to be included in the study only if she meets all of the following criteria:
1. Has provided written informed consent for the study;
2. Is a premenopausal woman, 18 to 50 years of age (inclusive). Patients entering from study MVT-601-050 are able to enroll if they met this inclusion criteria during the screening period of their preceding study;
3. Has either of the following conditions: a. A diagnosis of uterine fibroids confirmed by imaging or review of medical records and reports heavy menstrual bleeding negatively affecting quality of life (See Section 8.2.1 for screening questions); Note: The investigator should carefully consider the risks and benefits of participation for women with only Type 0 or Type 1 fibroids as defined by the International Federation of Gynecology and Obstetrics (FIGO) (Munro et al. 2011) due to the risk for uterine fibroid prolapse or expulsion; or b. A diagnosis of endometriosis (see note) that is associated with moderate to severe pain (See Section 8.2.1 for screening questions); Note: Patients with endometriosis must have surgical confirmation (by operative report or pathology report) or medical records indicating that the patient has a diagnosis of endometriosis and the investigator attests there is no other explanation for moderate to severe pelvic pain;
4. If at risk of pregnancy is willing to avoid pregnancy for 4 years (the duration of the treatment period) using nonhormonal methods of contraception;
5. Has a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at the allocation visit (or Month 12 if entering from MVT-601-050);
6. In good physical and mental health based on medical, surgical, and gynecological history as well as physical, gynecological, and breast examinations, clinical laboratory test results, and vital sign measurements;
7. Has a body mass index (BMI) ≥ 18 kg/m2 .