SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-As… (NCT03654274) | Clinical Trial Compass
CompletedPhase 3
SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain
United States802 participantsStarted 2018-05-22
Plain-language 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).
Who can participate
Age range18 Years – 51 Years
SexFEMALE
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Inclusion criteria
✓. Completed 24 weeks of study drug treatment and study participation in either parent study, MVT-601-3101 or MVT-601-3102.
✓. 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.
✓. Has agreed to continue to use only study-specified analgesic medications during the study and is not known to be intolerant to these.
Exclusion criteria
✕. Has had a surgical procedure for treatment for endometriosis at any time during the parent study (MVT-601-3101 or MVT-601-3102).
✕. 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.
✕. 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.
✕. Has any contraindication to treatment with low-dose E2 and NETA, including:
✕. Known, suspected, or history of breast cancer;
✕. Known or suspected estrogen-dependent neoplasia;
✕. Active deep vein thrombosis or pulmonary embolism, or history of these conditions prior to the Week 24/Baseline visit;
What they're measuring
1
Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 52
Timeframe: Week 52
2
Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 52
Timeframe: Week 52
3
Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 104
Timeframe: Week 104
4
Percentage Of Participants Who Meet The NMPP Responder Criteria At Week 104