Effect of Estetrol Monohydrate (E4) on QTc Interval
Status:
Recruiting
Trial end date:
2021-07-06
Target enrollment:
Participant gender:
Summary
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.