SPIRIT 1: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain

Completed · Phase 3 · Has a placebo group

Conditions studied: Endometriosis Related Pain

In brief

The purpose of this study is to determine the benefit and safety of relugolix 40 milligrams (mg) once daily, co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) compared with placebo for 24 weeks, on dysmenorrhea and on nonmenstrual pelvic pain.

Key facts

Study ID

NCT03204318

Run by

Myovant Sciences GmbH

People needed

638

Starts

2017-12-07

Expected to finish

2021-04-08

Last updated by the study team

2021-06-28

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

Where it is running

• Mesa — Mesa, Arizona, United States
• Scottsdale — Scottsdale, Arizona, United States
• Tucson — Tucson, Arizona, United States
• Tucson — Tucson, Arizona, United States
• Canoga Park — Canoga Park, California, United States
• Long Beach — Long Beach, California, United States
• San Diego — San Diego, California, United States
• Greenwood Village — Greenwood Village, Colorado, United States
• Fort Myers — Fort Myers, Florida, United States
• Loxahatchee — Loxahatchee Groves, Florida, United States
• Miami — Miami, Florida, United States
• Miami — Miami, Florida, United States
• Orlando — Orlando, Florida, United States
• Oviedo — Oviedo, Florida, United States
• Plantation — Plantation, Florida, United States
• Sarasota — Sarasota, Florida, United States
• Atlanta — Atlanta, Georgia, United States
• Augusta — Augusta, Georgia, United States
• Norcross — Norcross, Georgia, United States
• Idaho Falls — Idaho Falls, Idaho, United States
• Oakbrook — Oak Brook, Illinois, United States
• Shawnee — Shawnee Mission, Kansas, United States
• New Orleans — New Orleans, Louisiana, United States
• Jefferson City — Jefferson City, Missouri, United States
• Dothan — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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