How effective is Aila Gokna's treatment?

Two similar, double-blind, randomized, 6-month Phase 3 trials (Elaris Endometriosis I and II [EM-, INCT01620528 and EM-II, NCT01931670]) were conducted to evaluate two doses of Elaris (150 mg once daily (low-dose group) and 200 mg once daily) compared with placebo. mg twice daily (high-dose group) in women with surgical diagnosis of endometriosis and moderate-to-severe endometriosis-related pain. The two primary efficacy endpoints were the proportion of women with clinical response to dysmenorrhea and clinical response to nonmenstrual pelvic pain at 3 months. Each of these endpoints was measured as a clinically meaningful reduction in pain scores and reduction or stabilization of rescue analgesic use, as recorded in a daily electronic diary.

Results: A total of 872 women were randomized to Elaris EM-I and 817 to Elaris EM-II; of these women, 653 (74.9%) and 632 (77.4%), respectively, completed the intervention. At 3 months, a significantly higher proportion of women who received each dose of Elagokna met clinical response criteria for both primary endpoints compared with women who received placebo.

In Elaris EM-I, the proportion of women with a clinical response to dysmenorrhea was 46.4% in the low-dose group and 75.8% in the high-dose elagolis group, compared with 19.6% in the placebo group; in Elaris EM-II, the corresponding percentages were 43.4% and 72.4%, respectively, compared with 22.7% (all comparisons <0.001). In Elaris EM-I, the proportion of women with a clinical response to non-transvaginal pelvic pain was 50.4% in the low-dose Elagokana group and 54.5% in the high-dose Elagokana group compared with 36.5% in the placebo group (all comparisons <0.001); in Elaris In EM-II, the corresponding percentages were 49.8% and 57.8%, respectively, and 36.5% (P=0.003 and P<0.001, respectively).

Reactions with dysmenorrhea and nonmenstrual pelvic pain persisted at 6 months. Compared with women who took a placebo, women who took Elagokna had a higher incidence of hot flashes (mostly mild or moderate), higher blood lipid levels, and a greater decrease in bone density from baseline; the endometrium was not seen.

CONCLUSIONS: In women with endometriosis-related pain, both high and low doses of Elagokna were effective in improving dysmenorrhea and non-transvaginal pelvic pain over a 6-month period. Two doses of Elagokna were associated with hypoestrogenic adverse effects.

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