Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening

Status: Completed
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 99
Healthy Volunteers: t
View:

⁃ Postmenopausal Women:

• Age 50-99 years old

• Postmenopausal (have not has a menstrual period for 12 months or longer)

⁃ Older Men:

⁃ • Age 65 years old to 99 years old

Locations
United States
Indiana
Indiana Clinical Research Center
Indianapolis
Indiana University
Indianapolis
Purdue University
Indianapolis
Time Frame
Start Date: 2021-09-02
Completion Date: 2025-04-16
Participants
Target number of participants: 73
Treatments
Experimental: Postmenopausal women: Progesterone
Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Placebo_comparator: Postmenopausal women: Placebo
Subjects will receive oral placebo, two capsules once daily every evening for 7 days
Experimental: Men 65 years of age or older: Testosterone
Subjects will receive treatment with transdermal testosterone 1% (100 mg) every morning for 3 days
Placebo_comparator: Men 65 years of age or older: Placebo
Subjects will receive treatment with transdermal placebo every morning for 3 days
Authors
David Flockhart, Richard J Kovacs
Related Therapeutic Areas
Sponsors
Leads: Indiana University
Collaborators: Cedars-Sinai Medical Center, Purdue University, National Heart, Lung, and Blood Institute (NHLBI), Harvard University

This content was sourced from clinicaltrials.gov

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