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Key clinical point: Relugolix monotherapy effectively reduced menstrual blood loss associated with uterine leiomyomas (UL) along with an acceptable tolerability profile.
Major finding: Between weeks 6 to 12, the proportion of patients with pictorial blood loss assessment chart score of less than 10 was higher in relugolix 40 mg (difference vs placebo [D], 83.3%), 20 mg (D, 42.6%), and 10 mg (D, 20.8%) treatment arms (all P < .001). Treatment-emergent adverse events were mostly mild/moderate but were more frequent in relugolix arm (85.4%-96.4%%) vs placebo (70.2%).
Study details: Findings are from a phase 2 trial, including 216 premenopausal women with UL who were randomly assigned 1:1:1:1 to receive relugolix 10 mg, 20 mg, 30 mg, 40 mg, or placebo.
Disclosures: This study was funded by Takeda Pharmaceutical Company. The lead author reported receiving consultancy fees from Takeda Pharmaceutical Company, and other authors reported being current/former employees of the company.
Source: Hoshiai H et al. BMC Womens Health. 2021 Oct 28. doi: 10.1186/s12905-021-01475-2.
Key clinical point: Relugolix monotherapy effectively reduced menstrual blood loss associated with uterine leiomyomas (UL) along with an acceptable tolerability profile.
Major finding: Between weeks 6 to 12, the proportion of patients with pictorial blood loss assessment chart score of less than 10 was higher in relugolix 40 mg (difference vs placebo [D], 83.3%), 20 mg (D, 42.6%), and 10 mg (D, 20.8%) treatment arms (all P < .001). Treatment-emergent adverse events were mostly mild/moderate but were more frequent in relugolix arm (85.4%-96.4%%) vs placebo (70.2%).
Study details: Findings are from a phase 2 trial, including 216 premenopausal women with UL who were randomly assigned 1:1:1:1 to receive relugolix 10 mg, 20 mg, 30 mg, 40 mg, or placebo.
Disclosures: This study was funded by Takeda Pharmaceutical Company. The lead author reported receiving consultancy fees from Takeda Pharmaceutical Company, and other authors reported being current/former employees of the company.
Source: Hoshiai H et al. BMC Womens Health. 2021 Oct 28. doi: 10.1186/s12905-021-01475-2.
Key clinical point: Relugolix monotherapy effectively reduced menstrual blood loss associated with uterine leiomyomas (UL) along with an acceptable tolerability profile.
Major finding: Between weeks 6 to 12, the proportion of patients with pictorial blood loss assessment chart score of less than 10 was higher in relugolix 40 mg (difference vs placebo [D], 83.3%), 20 mg (D, 42.6%), and 10 mg (D, 20.8%) treatment arms (all P < .001). Treatment-emergent adverse events were mostly mild/moderate but were more frequent in relugolix arm (85.4%-96.4%%) vs placebo (70.2%).
Study details: Findings are from a phase 2 trial, including 216 premenopausal women with UL who were randomly assigned 1:1:1:1 to receive relugolix 10 mg, 20 mg, 30 mg, 40 mg, or placebo.
Disclosures: This study was funded by Takeda Pharmaceutical Company. The lead author reported receiving consultancy fees from Takeda Pharmaceutical Company, and other authors reported being current/former employees of the company.
Source: Hoshiai H et al. BMC Womens Health. 2021 Oct 28. doi: 10.1186/s12905-021-01475-2.