Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening: Reducing the Risk of Drug-Induced QT Interval Lengthening in Women

Who is this study for? Patients with Long QT Syndrome, Drug-Induced Abnormalities
What treatments are being studied? Ibutilide
Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 21
Healthy Volunteers: t
View:

⁃ Postmenopausal women:

• 50 years of age or older

• No menstrual periods for 365 days or longer

⁃ Premenopausal women:

⁃ \- 21-40 years of age

Locations
United States
Indiana
Indiana University
Indianapolis
Time Frame
Start Date: 2019-03-26
Completion Date: 2024-05-23
Participants
Target number of participants: 27
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: Premenopausal 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: Premenopausal women: Placebo
Subjects will receive oral placebo, two capsules once daily every evening for 7 days
Related Therapeutic Areas
Sponsors
Collaborators: Purdue University, American Heart Association
Leads: Indiana University

This content was sourced from clinicaltrials.gov