drugset / Trial / NCT05325775

Dose-ranging, PK, Safety, Efficacy Study of Osanetant in Patients With Moderate/Severe VMS Associated With Menopause

NCT05325775 ↗

Phase 1/2 Completed 49 enrolled Acer Therapeutics Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

In this clinical research study, subjects will be given the study drug, ACER-801 (osanetant) or placebo (looks like the study drug but contains no active ingredients). The study drug works on a receptor in the brain and the intended purpose is for the study treatment of moderate to severe Vasomotor Symptoms (VMS) also referred to as hot flashes or flushes associated with menopause. Hot flashes are a change in your temperature that occurs due to changes in your hormones.

Timeline

Start
2022-03-30
Primary completion
2023-03-04
Completion
2023-03-04

Drugs

EvaluationDrugModalityDoseRoute
Subject ACER-801 Unknown 50 mg —
Subject ACER-801 Unknown 100 mg —
Subject ACER-801 Unknown 200 mg —

Indications

No indication recorded.