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

NCT05325775 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2024-08-07

Study results available
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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.

Conditions

  • Post-menopausal Vasomotor Symptoms

Interventions

DRUG

ACER-801 50 mg BID

50 mg BID (twice daily)

DRUG

ACER-801 100 mg BID

100 mg BID (twice daily)

DRUG

ACER-801 200 mg BID

200 mg BID (twice daily)

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Acer Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Jennifer Boston, MSN, APNP · Spaulding Clinical Research LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-30
Primary Completion
2023-03-04
Completion
2023-03-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05325775 on ClinicalTrials.gov