Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening

PHASE4CompletedINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

September 2, 2021

Primary Completion Date

April 16, 2025

Study Completion Date

April 16, 2025

Conditions
Long QT SyndromeAbnormalities, Drug-Induced
Interventions
DRUG

Progesterone

Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days

DRUG

Ibutilide

Ibutilide 0.003 mg/kg administered to all subjects to modestly lengthen the QT interval

DRUG

Testosterone

Subjects will apply transdermal testosterone gel once daily every morning for 3 days

DRUG

Placebo

Lactose capsules

Trial Locations (3)

46202

Indiana Clinical Research Center, Indianapolis

Indiana University, Indianapolis

Purdue University, Indianapolis

All Listed Sponsors
collaborator

Purdue University

OTHER

collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

Harvard University

OTHER

collaborator

Cedars-Sinai Medical Center

OTHER

lead

Indiana University

OTHER

NCT04675788 - Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening | Biotech Hunter | Biotech Hunter