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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Post-menopausal Vasomotor Symptoms

In brief

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.

Key facts

Study ID

NCT02865538

Run by

Bayer

People needed

76

Starts

2016-08-01

Expected to finish

2017-03-28

Last updated by the study team

2025-02-07

Who can join

Age: 45 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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