Influence of Testosterone Administration on Drug-Induced QT Interval Prolongation and Torsades de Pointes

PHASE4CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

May 31, 2016

Primary Completion Date

October 19, 2017

Study Completion Date

October 19, 2017

Conditions
Long QT Syndrome
Interventions
DRUG

Testosterone

Subjects will receive transdermal testosterone gel 1% 100 mg daily for 7 days

DRUG

Progesterone

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

DRUG

Placebo

Subjects will receive placebo transdermal gel and placebo (lactose) capsules

DRUG

Ibutilide

Ibutilide 0.003 mg/kg administered to all subjects in all phases to moderately lengthen the QT interval

Trial Locations (1)

46202

Indiana University, Indianapolis

All Listed Sponsors
collaborator

American Heart Association

OTHER

collaborator

Purdue University

OTHER

lead

Indiana University

OTHER

NCT02513940 - Influence of Testosterone Administration on Drug-Induced QT Interval Prolongation and Torsades de Pointes | Biotech Hunter | Biotech Hunter