SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain
Condition: Endometriosis
MeSH terms: Endometriosis
Intervention: Relugolix; Estradiol/norethindrone acetate
Intervention description: Relugolix 40-mg tablet administered orally once daily; Capsule containing co-formulated tablet of E2 (1.0 mg) and NETA (0.5 mg) administered orally once daily
Intervention MeSH terms: Norethindrone; Norethindrone Acetate; Estradiol; Relugolix
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open label extension
Masking: None (Open Label)
Enrollment: 802.0
Sex: Female
Minimum age: 18 Years
Maximum age: 51 Years
Healthy volunteers: No
Keywords: Endometriosis; Dysmenorrhea; Pain; Dyspareunia; Pelvic Pain

Summary:

      The purpose of this study is to evaluate the long-term efficacy and safety of relugolix 40
      milligram (mg) once daily co-administered with low-dose estradiol (E2) and norethindrone
      acetate (NETA) for up to 104 weeks on endometriosis-associated pain in participants who
      previously completed a 24-week treatment period in one of the parent studies (MVT-601-3101 or
      MVT-601-3102).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Completed 24 weeks of study drug treatment and study participation in either parent
             study, MVT-601-3101 or MVT-601-3102.

          2. Is not expected to undergo gynecological surgery or other surgical procedures for
             treatment of endometriosis (including ablation, shaving, or excision) during the
             study, including during the Follow-Up Period, and the participant does not desire such
             treatment during this time frame.

          3. Has agreed to continue to use only study-specified analgesic medications during the
             study and is not known to be intolerant to these.

        Key Exclusion Criteria:

          1. Has had a surgical procedure for treatment for endometriosis at any time during the
             parent study (MVT-601-3101 or MVT-601-3102).

          2. Has any chronic pain or frequently recurring pain condition, other than endometriosis,
             that is treated with opioids or requires analgesics for ≥ 7 days per month.

          3. Has a Z-score < -2.0 or has a ≥ 7% decrease in bone mineral density from the parent
             study Baseline at lumbar spine, total hip, or femoral neck based on the parent study
             Week 24 DXA assessment of bone mineral density.

          4. Has any contraindication to treatment with low-dose E2 and NETA, including:

               1. Known, suspected, or history of breast cancer;

               2. Known or suspected estrogen-dependent neoplasia;

               3. Active deep vein thrombosis or pulmonary embolism, or history of these conditions
                  prior to the Week 24/Baseline visit;

               4. History of or active arterial thromboembolic disease, including stroke and
                  myocardial infarction;

               5. Known anaphylactic reaction or angioedema or hypersensitivity to E2 or NETA;

               6. Known protein C, protein S, or antithrombin deficiency, or other known
                  thrombophilia disorders, including Factor V Leiden;

               7. Migraine with aura;

               8. History of porphyria.

          5. Had any of the following clinical laboratory abnormalities at the parent study Week 20
             visit or, if available, any subsequent visit in one of the parent studies
             (MVT-601-3101 or MVT-601-3102):

               1. Alanine aminotransferase or aspartate aminotransferase > 2.0 times the upper
                  limit of normal (ULN); or

               2. Bilirubin (total bilirubin) > 1.5 x ULN (or > 2.0 x ULN if secondary to Gilbert
                  syndrome or pattern consistent with Gilbert syndrome).