SPIRIT 2: 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

NCT03204331

Run by

Myovant Sciences GmbH

People needed

623

Starts

2017-11-01

Expected to finish

2021-05-31

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

• Washington DC — Washington D.C., District of Columbia, United States
• Aventura — Aventura, Florida, United States
• Deland — DeLand, Florida, United States
• Hialeah — Hialeah, Florida, United States
• Hialeah — Hialeah, Florida, United States
• Margate — Margate, Florida, United States
• Miami — Miami, Florida, United States
• Port St. Lucie — Port Saint Lucie, Florida, United States
• Tampa — Tampa, Florida, United States
• Atlanta — Atlanta, Georgia, United States
• Idaho Falls — Idaho Falls, Idaho, United States
• Park Ridge — Park Ridge, Illinois, United States
• Lafayette — Lafayette, Indiana, United States
• Covington — Covington, Louisiana, United States
• Marrero — Marrero, Louisiana, United States
• Towson — Towson, Maryland, United States
• Saginaw — Saginaw, Michigan, United States
• St. Louis — St Louis, Missouri, United States
• Omaha — Omaha, Nebraska, United States
• Albuquerque — Albuquerque, New Mexico, United States
• New York — New York, New York, United States
• New Bern — New Bern, North Carolina, United States
• Akron — Akron, Ohio, United States
• Columbus — Columbus, Ohio, United States
• Andalusia — Andalusia, Alabama, United States

Full record on ClinicalTrials.gov

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