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Evaluation of the Pharmacokinetics and Safety of BAY3427080 (NT-814) in Post-Menopausal Women With Vasomotor Symptoms | Clinical Trials | Clareo Health

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Evaluation of the Pharmacokinetics and Safety of BAY3427080 (NT-814) in Post-Menopausal Women With Vasomotor Symptoms

Evaluation of the Pharmacokinetics and Safety of NT-814 in Post-Menopausal Women With Vasomotor Symptoms

NCT02865538•Bayer

View on ClinicalTrials.gov

Summary

This is a multi-center, double-blind, randomized, placebo-controlled multiple ascending dose study in post-menopausal women with vasomotor symptoms. Single ascending doses of NT-814 will be investigated in 4 cohorts. Each cohort will comprise of 20 subjects. Subjects will be dosed for 14 days.

Eligibility

Age

45 - 65 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Post-menopausal female subjects experiencing frequent moderate to severe hot flashes.Menopause will be defined as:
•* 12 months of spontaneous amenorrhea;
•* OR at least 6 weeks' post-surgical bilateral oophorectomy with or without hysterectomy.

Exclusion Criteria

•BMI \> 35kg/m2.
•Any active comorbid disease, ECG or laboratory result deemed by the investigator to be clinically significant and which could impact safety during study conduct or that could interfere with the study evaluation, procedures or completion.
•Use of prohibited medications defined in the protocol.
•Inability or unwillingness to comply with study procedures or requirements.

Locations (3)

Avail Clinical Research

DeLand, Florida, United States

QPS/MRA (Miami Clinical Research)

Miami, Florida, United States

ICON Clinical Research Unit

San Antonio, Texas, United States

Key Dates

Start Date

August 1, 2016

Primary Completion Date

March 28, 2017

Completion Date

March 28, 2017

Last Updated

February 7, 2025

Enrollment

ACTUAL participants

Conditions

Post-menopausal Vasomotor Symptoms

Interventions

BAY3427080

DRUG

Placebo (for BAY3427080)

DRUG