Clinical Trial 55389

West Palm Beach, FL 33409


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


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 .

Qualified Participants May Receive:

Study related tests, blood work, procedures, imaging, and overall care. They will also receive compensation for time and travel.

Available At:

Comprehensive Clinical Research
603 Village blvd ste 301
West Palm Beach, FL 33409
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If you or someone you care for is interested in participating and lives within 50 miles of the location shown, please complete the form below and click 'Submit'

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.