Reducing the Risk of Drug-Induced QT Interval Lengthening in Women
Status:
Recruiting
Trial end date:
2022-06-30
Target enrollment:
Participant gender:
Summary
This research will determine if oral progesterone attenuates drug-induced QT interval
lengthening in a) Postmenopausal women 50 years of age or older, and b) Premenopausal women
studied during the ovulation phase of the menstrual cycle. This investigation will consist of
two concurrent prospective, randomized, double-blind, placebo-controlled crossover-design
studies in a) Postmenopausal women, and b) Premenopausal women. Each subject will take
progesterone or placebo capsules for 1 week. After a two-week "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