Effect of Estetrol Monohydrate (E4) on QTc Interval

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2021
The purpose of this study is: * to evaluate if E4 has any effect on how the heart beats when a single dose is given at two different dose levels; * to determine the ability to detect small changes in how the heart beats using a positive control: moxifloxacin, a quinolone antibiotic approved by the FDA as a positive control in thorough QT (TQT) studies; * to assess the safety and tolerability of a single dose of E4 administered at two different dose levels; * to measure the amount of study drug in the blood stream and how long it takes for the body to eliminate it (Pharmacokinetics) after administration.
Epistemonikos ID: 215352526d3b52925cd0fd571de425772d302eaa
First added on: May 08, 2024