Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: OASIS 1 and 2 Randomized Clinical Trials.

ABSTRACT:

Importance

Safe and effective nonhormonal treatments for menopausal vasomotor symptoms (VMS) are needed.

Objective

To evaluate the efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist, for the treatment of moderate to severe menopausal vasomotor symptoms.

Design, setting, and participants

Two randomized double-blind phase 3 trials (OASIS 1 and 2) included postmenopausal participants aged 40 to 65 years experiencing moderate to severe vasomotor symptoms (OASIS 1: 77 sites in the US, Europe, and Israel from August 27, 2021, to November 27, 2023, and OASIS 2: 77 sites in the US, Canada, and Europe from October 29, 2021, to October 10, 2023).

Intervention

Once daily oral elinzanetant, 120 mg, for 26 weeks or matching placebo for 12 we

SUBMITTER: Pinkerton JV 

PROVIDER: S-EPMC11342219 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature