Study Information

Study Design1,2

Study Population1,2

Premenopausal women 18–50 with surgically or directly visualised endometriosis with or without histological confirmation, or with histological diagnosis alone.

Co-Primary Endpoints1,2

Proportion of responders to Ryeqo based on the dysmenorrhoea and NMPP NRS scores
(24 weeks vs placebo in SPIRIT 1 and 2, 1 and 2 years in the long-term extension)

Key Secondary Endpoints1,2

  • Pain (change in EHP-30 pain domain score)
  • Dysmenorrhoea (change in average NRS score)
  • NMPP (change in average NRS score)
  • Overall pelvic pain (change in average NRS score)
  • Dyspareunia (change in average NRS score)
  • Proportion of patients not using opioids for endometriosis-associated pain
  • Proportion of patients not using analgesics for endometriosis-associated pain (SPIRIT 1 and the long-term extension) or change from baseline in analgesic use (based on average daily pill count; SPIRIT 2)
For more information on the SPIRIT studies please see the full publication:

*Ryeqo contains 40 mg relugolix, 1 mg estradiol and 0.5 mg norethisterone acetate.3

Abbreviations: EHP-30, Endometriosis Health Profile-30; NMPP, non-menstrual pelvic pain; NRS, Numerical Rating Scale.

References

  • Giudice LC et al. Lancet. 2022;399:2267–2279.
  • Becker CM et al. Hum Reprod 2024;39(3):526–537.
  • Ryeqo Approved Product Information. January 2024.