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Effect of Estetrol Monohydrate (E4) on QTc Interval

NCT04819906 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-09-15

No results posted yet for this 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.

Conditions

  • Prolonged QTc Interval

Interventions

DRUG

Estetrol 20 mg

One estetrol monohydrate (E4) 20 mg tablet plus four matching placebo tablets orally once

DRUG

Estetrol 100 mg

Five estetrol monohydrate (E4) 20 mg tablets orally once

DRUG

Placebo

Five placebo tablets orally once

DRUG

Moxifloxacin 400 mg

One moxifloxacin 400 mg tablet orally once (open-label)

Sponsors & Collaborators

  • Estetra

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-09
Primary Completion
2021-07-14
Completion
2021-07-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04819906 on ClinicalTrials.gov