American College of Obstetrics and Gynecology Annual Clinical and Scientific Meeting

American College of Obstetrics and Gynecology Annual Clinical and Scientific Meeting

Source:

Lukes AS, et al. Abstract 78. Presented at: ACOG Annual Clinical & Scientific Meeting; May 6-8, 2022; San Diego.

Disclosures: Lukes reports consulting for AbbVie and Myovant, and being a principal investigator for AbbVie, Bayer, Gynesonics, Merck, Myovant and ObsEva.
May 11, 2022
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Most women taking relugolix for uterine fibroid-related heavy menses achieve amenorrhea

Source:

Lukes AS, et al. Abstract 78. Presented at: ACOG Annual Clinical & Scientific Meeting; May 6-8, 2022; San Diego.

Disclosures: Lukes reports consulting for AbbVie and Myovant, and being a principal investigator for AbbVie, Bayer, Gynesonics, Merck, Myovant and ObsEva.
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SAN DIEGO — About 70% of women with uterine fibroid-related heavy menstrual bleeding who took relugolix combination therapy experienced amenorrhea, according to data presented at the ACOG Annual Clinical & Scientific Meeting.

“Of the remaining women who had either cyclic or irregular bleeding, approximately half had spotting or light or moderate bleeding that was considered within the normal range for menstrual blood loss,” Andrea S. Lukes, MD, MHSc, FACOG, principal investigator of the study and founder of Carolina Women’s Research and Wellness Center in Durham, North Carolina, told Healio.

Most women with uterine fibroids and heavy menstrual bleeding experienced amenorrhea when taking relugolix. Source: Adobe Stock
Most women with uterine fibroids and heavy menstrual bleeding experienced amenorrhea when taking relugolix. Source: Adobe Stock

Lukes and colleagues analyzed the bleeding patterns and intensity of 327 premenopausal women with uterine fibroid-related heavy menstrual bleeding recorded in daily diary entries for 52 weeks or through the end of treatment with relugolix combination therapy. Combination therapy included once-daily relugolix 40 mg, estradiol 1 mg and norethindrone acetate 0.5 mg.

Researchers included women who completed 24 weeks of treatment in either LIBERTY 1 or 2 study — both of which were phase 3, placebo-controlled studies that determined that relugolix combination therapy improved heavy menses related to uterine fibroids — who agreed to participate in the present 28-week extension study.

Within the study population, 163 women continued relugolix combination therapy and 164 switched to combination therapy after having taken placebo during LIBERTY 1 or 2.

Data revealed that 86.5% of women who continued combination therapy and 75% who switched to combination therapy responded to treatment by the end of the study, with 70.6% and 57.9% achieving amenorrhea, respectively.

Among those who continued treatment, 15 (9.2%) women experienced cyclic bleeding, with five (3.1%) experiencing continued heavy menstrual bleeding. Additionally, 33 (20.2%) women who continued treatment had irregular bleeding, with 10 (6.1%) having continued heavy menstrual bleeding.

Among women who switched from placebo, 25 (15.2%) experienced cyclic bleeding, with 15 (9.1%) experiencing continued heavy menses. Also, 44 (26.8%) women experienced irregular bleeding, nine (5.5%) of whom continued to experience heavy menstrual bleeding.

Andrea S. Lukes, MD, MHSc, FACOG
Andrea S. Lukes

“Women with heavy menstrual bleeding associated with uterine fibroids who take relugolix combination therapy for a year will have changes in their bleeding pattern associated with the treatment effect of the drug,” Lukes said. “These data suggest that the majority of women should expect to see amenorrhea.”