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A Study With an Open-Label Active Control to Evaluate the Potential of Nestorone® to Delay Cardiac Repolarization in Healthy Female Volunteers

NCT02236026 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2017-08-15

No results posted yet for this study

Summary

The purpose of the study is to evaluate the effect of Nestorone (NES) administered as an bolus injection on the corrected QT interval using Fridericia's formula (QTcF).

Conditions

  • Healthy

Interventions

DRUG

Supratherapuetic dose of Nestorone

DRUG

Placebo

DRUG

Moxifloxacin

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Population Council

    lead OTHER

Principal Investigators

  • George W. Creasy, MD · Population Council

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-12-31
Completion
2015-12-31

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 NCT02236026 on ClinicalTrials.gov