Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening
Status:
Recruiting
Trial end date:
2025-08-31
Target enrollment:
Participant gender:
Summary
This research will determine if: 1) Oral progesterone attenuates drug-induced QT interval,
J-Tpeak and Tpeak-Tend lengthening in postmenopausal women 50 years of age or older, and 2)
Transdermal testosterone attenuates drug-induced QT interval, J-Tpeak and Tpeak-Tend
lengthening in men 65 years of age or older. This investigation will consist of two
concurrent prospective, randomized, double-blind, placebo-controlled crossover-design studies
in a) Postmenopausal women, and b) Men 65 years of age or older. Study 1: Each postmenopausal
woman will take progesterone or placebo capsules for 1 week. After a 14-day "washout" (no
progesterone or placebo) each subject will then take the alternative therapy (progesterone or
placebo) for 1 week. After 7 days of each treatment, subjects will present to the clinical
research center to receive a small dose of the QT interval-lengthening drug ibutilide, and
the effect on the QT, J-Tpeak and Tpeak-Tend intervals during the progesterone and placebo
phases will be compared. Study 2: Each man 65 years of age or older will apply transdermal
testosterone or transdermal placebo gel for 3 days. After a 7-day "washout" (no testosterone
or placebo) each subject will then apply the alternative therapy (testosterone or placebo
gel) for 1 week. After 3 days of each treatment, subjects will present to the clinical
research center to receive a small dose of the QT interval-lengthening drug ibutilide, and
the effect on the QT, J-Tpeak and Tpeak-Tend intervals during the testosterone and placebo
phases will be compared.
Phase:
Phase 4
Details
Lead Sponsor:
Indiana University
Collaborators:
Cedars-Sinai Medical Center Harvard University National Heart, Lung, and Blood Institute (NHLBI) Purdue University