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COMPLETED
NCT04675788
PHASE4

Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening

Sponsor: Indiana University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

50 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

73

Start Date

2021-09-02

Completion Date

2025-04-16

Last Updated

2026-10-20

Healthy Volunteers

Yes

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

Locations (3)

Indiana Clinical Research Center

Indianapolis, Indiana, United States

Indiana University

Indianapolis, Indiana, United States

Purdue University

Indianapolis, Indiana, United States