Human medicines European public assessment report (EPAR): Ryeqo, relugolix,estradiol,norethisterone acetate, Leiomyoma, Date of authorisation: 16/07/2021, Revision: 6, Status: Authorised
Uterine fibroids
Ryeqo has been shown to be effective in treating symptoms linked to uterine fibroids in two studies involving women of reproductive age (from 18 to 50 years) with heavy menstrual bleeding. In both studies, around 500 women received either Ryeqo or placebo (a dummy treatment) for 24 weeks.
In the first study, 73% (94 out of 128) of women using Ryeqo reported monthly menstrual blood loss of fewer than 80 mL and at least 50% less blood loss than before the treatment, compared with 19% (24 out of 128) of those taking placebo. In the second study, 71% (89 out of 126) achieved this reduction in the volume of blood lost while using Ryeqo, compared with 15% (19 out of 129) of those given the placebo.
Endometriosis
Ryeqo has been also shown to be effective in treating symptoms of endometriosis in two studies involving women of reproductive age (from 18 to 50 years) with symptoms of moderate-to-severe pain. In both studies, around 630 patients received either Ryeqo or placebo for 24 weeks.
In the first study, 75% (158 out of 212) of women using Ryeqo reported a reduction in menstrual pain compared with 27% (57 out of 212) of those taking placebo. The proportion of women with a reduction in non-menstrual pain was also higher with Ryeqo (59%) than with placebo (40%).
In the second study, 75% (155 out of 206) achieved a reduction in menstrual pain while using Ryeqo, compared with 31% (62 out of 204) of those given the placebo. In addition, the proportion of women with a reduction in non-menstrual pain was higher among those who had Ryeqo (66%) than those who had placebo (43%).
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