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Uterine Leiomyoma Associated Pain Treated Effectively by Relugolix Combination Therapy

Published On 2022-05-27T10:00:53+05:30  |  Updated On 27 May 2022 4:30 AM GMT
Uterine Leiomyoma Associated Pain Treated Effectively by Relugolix Combination Therapy

Overview

A new study in Obstetrics & Gynecology journal points that Relugolix-CT was effective and significantly reduced moderate-to-severe uterine leiomyoma-associated pain with a more pronounced effect on menstrual pain.

The effect of once-daily relugolix combination therapy was assessed in a combination of relugolix-CT: relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg, compared with placebo on moderate-to-severe pain in women with uterine leiomyomas and heavy menstrual bleeding.

A multinational, double-blind, 24-week, randomized, phase 3 studies "LIBERTY 1 and 2" were conducted in premenopausal women with uterine leiomyoma–associated heavy menstrual bleeding. A predefined secondary objective was to determine the effect of Relugolix-CT on moderate-to-severe uterine leiomyoma–associated pain in the pain subpopulation. The key secondary endpoint was defined as the proportion of women achieving minimal-to-no uterine leiomyoma–associated pain at week 24; menstrual and nonmenstrual pain were evaluated in prespecified secondary analyses. Treatment comparisons were performed in the pooled LIBERTY 1 and 2 pain subpopulation using the Cochran-Mantel-Haenszel test stratified by baseline menstrual blood loss volume.

A total of 509 women were randomized from both trials to relugolix-CT or placebo. Of these, 277 (54.4%) met pain subpopulation requirements. With relugolix-CT, 45.2% of women achieved minimal-to-no pain compared with 13.9% with placebo. The proportions of women with minimal-to-no pain during menstrual days and during nonmenstrual days were significantly higher with relugolix-CT 65.0% and 44.6% compared with placebo 19.3% , and 21.6%.

Researchers concluded that over 24 weeks, relugolix-CT significantly reduced moderate-to- severe uterine leiomyoma–associated pain with a more pronounced effect on menstrual pain. These data support that relugolix-CT had clinically meaningful effects on women's experience of uterine leiomyoma–associated pain.

Speakers

Dr Priyanka Ahuja

MBBS- MAMC Delhi, MS(Obstetrics & Gynaecology)

MBBS- MAMC Delhi, MS(Obstetrics & Gynaecology) - MUHS, Senior Residency- Safdarjung Hospital . Won numerous awards in the same field. Her interest lies in the field of Obstetrics, women and child health. At Medical Dialogues she talks about latest research in the field of Obstetrics, Gynaecology and Women Health. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751
Uterine Leiomyoma Relugolix Combination Therapy menstrual bleeding uterine leiomyoma Obstetrics & Gynecology menstrual pain 
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