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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: Completed Phase 1 study, sponsored by Estetra.
NCT04819906 is a Phase 1 study that has completed, run by Estetra. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Continuous 12-lead ECG (Holters) recordings will be performed. Baseline will be the average of the derived ECG intervals from the 3 predose ECG time points (-45, -30, and -15 minutes).
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 |
What the finished NCT04819906 record still lists
NCT04819906 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04819906 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT04819906's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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