Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04819906 · ClinicalTrials.gov registry record · Phase 1
Effect of Estetrol Monohydrate (E4) on QTc Interval
A Phase 1 study, sponsored by Estetra.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT04819906 is a Phase 1 study that has completed, run by Estetra. The registered enrollment target is 32 participants.
The verdict
NCT04819906, a Phase 1 study, has completed, sponsored by Estetra.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Moxifloxacin 400 mg
- DRUG Estetrol 20 mg
- DRUG Estetrol 100 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2021-03-09 |
| Est. Completion | 2021-07-14 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04819906
The ClinicalTrials.gov registry entry for NCT04819906 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Estetra, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04819906 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04819906 about?
NCT04819906 is a clinical study titled "Effect of Estetrol Monohydrate (E4) on QTc Interval". 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 ...
What is the current status of trial NCT04819906?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2021-03-09. Estimated completion is 2021-07-14.
What interventions are being tested in trial NCT04819906?
The interventions under investigation include: Placebo (DRUG), Moxifloxacin 400 mg (DRUG), Estetrol 20 mg (DRUG), Estetrol 100 mg (DRUG).
Who is sponsoring clinical trial NCT04819906?
This trial is sponsored by Estetra, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.