Relugolix / Estradiol / Norethisteronacetat (2) – Ryeqo®

• Clinical trials
  • The pharmaceutical manufacturer has submitted a meta-analysis of the two studies, SPIRIT 1 and SPIRIT 2, which have identical study designs. These are randomised, double-blind studies in which the efficacy and safety of the combination of relugolix and oestradiol (E2)/norethisterone acetate (NETA) were compared with placebo over a 24-week period.

Women of childbearing age with endometriosis who have already undergone medical or surgical treatment; for symptomatic treatment

• For women of childbearing age with endometriosis who have already received medical or surgical treatment (for symptomatic management), the additional benefit is not proven.
• Overall, the additional benefit for women of childbearing age with endometriosis who have already been treated with medication or surgery is not proven, as no suitable data are available for comparison with the specified appropriate comparator therapy.
• On balance, there are no suitable data available for comparison with the specified appropriate comparator therapy. The additional benefit for women of childbearing age with endometriosis who have already been treated with medication or surgery is therefore not proven.
• Overall assessment
  • Overall, the additional benefit for women of childbearing age with endometriosis who have already been treated with medication or surgery is not proven, as there are no suitable data available for comparison with the established appropriate comparator therapy.

Courtesy translation only, please refer to the German original.