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:
Treatment of Endometriosis with Relugolix Combination Therapy (SPIRIT 1 and 2)
Treating Endometriosis with Relugolix Combination Therapy for Two Years (SPIRIT Long-Term Extension)
*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.