Efficacy and safety of fezolinetant for moderate-severe vasomotor symptoms associated with menopause in individuals unsuitable for hormone therapy: phase 3b randomised controlled trial.

ABSTRACT:

Objectives

To assess the efficacy and safety of the non-hormonal, neurokinin 3 receptor antagonist, fezolinetant, to treat moderate-severe vasomotor symptoms associated with menopause in individuals unsuitable for hormone therapy.

Design

Phase 3b randomised controlled trial.

Setting

16 countries.

Participants

453 individuals aged 40-65 years with moderate-severe vasomotor symptoms associated with menopause who were considered unsuitable candidates for hormone therapy (contraindicated, caution (based on medical history), stoppers (previous discontinuation of hormone therapy), or averse (informed choice not to use hormone therapy)) were randomised to receive fezolinetant (n=227) or placebo (n=226).

Intervention

Fezolinetant 45 mg or placebo once daily for

SUBMITTER: Schaudig K 

PROVIDER: S-EPMC11571049 | biostudies-literature | 2024 Nov

REPOSITORIES: biostudies-literature