Relugolix combination therapy in European women with symptomatic uterine fibroids: a subgroup analysis from the randomized phase 3 LIBERTY pivotal trials.

European premenopausal women LIBERTY Uterine fibroids heavy menstrual bleeding relugolix combination therapy

Journal

Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology
ISSN: 1473-0766
Titre abrégé: Gynecol Endocrinol
Pays: England
ID NLM: 8807913

Informations de publication

Date de publication:
17 Aug 2023
Historique:
medline: 29 8 2023
pubmed: 28 8 2023
entrez: 27 8 2023
Statut: ppublish

Résumé

In the 24-week, phase 3 LIBERTY 1 (L1) and LIBERTY 2 (L2) trials, relugolix combination therapy (relugolix-CT (relugolix 40 mg, estradiol 1 mg, norethisterone acetate 0.5 mg)) reduced uterine fibroid (UF)-associated symptoms. This Premenopausal women (aged 18-50 years) with UF-associated heavy menstrual bleeding (HMB) were randomized 1:1:1 in L1 ( In European women from L1/L2 ( In European women with UF and HMB, once-daily relugolix-CT vs. placebo improved UF-associated symptoms and preserved BMD.

Identifiants

pubmed: 37634528
doi: 10.1080/09513590.2023.2249107
doi:

Substances chimiques

relugolix 0

Types de publication

Randomized Controlled Trial Clinical Trial, Phase III Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

2249107

Auteurs

Roberta Venturella (R)

Department of Clinical and Experimental Medicine, Unit of Obstetrics and Gynecology, Magna Graecia University of Catanzaro, Catanzaro, Italy.

Tomasz Rechberger (T)

Second Department of Gynecology, Medical University of Lublin, Lublin, Poland.

János Zatik (J)

Szent Anna Women's OB/GYN and Ultrasound Outpatient Clinic, Debrecen, Hungary.

Rachel B Wagman (RB)

Clinical Research, Sumitomo Pharma America, Inc., Brisbane, CA, USA.

Emily Zhu (E)

Development Operation, Sumitomo Pharma America, Inc., Brisbane, CA, USA.

Viatcheslav G Rakov (VG)

Research and Development, Myovant Sciences GmbH, Basel, Switzerland.

Felice Petraglia (F)

Department of Experimental, Clinical and Biomedical Sciences, Obstetrics and Gynecology, University of Florence, Careggi University Hospital, Florence, Italy.

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Classifications MeSH