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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03834883
Other study ID # 1806935117
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 26, 2019
Est. completion date May 23, 2024

Study information

Verified date March 2024
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Progesterone
Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days
Ibutilide
Ibutilide 0.003 mg/kg administered to all subjects to moderately lengthen the QT interval

Locations

Country Name City State
United States Indiana University Indianapolis Indiana

Sponsors (3)

Lead Sponsor Collaborator
Indiana University American Heart Association, Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Adverse effects Adverse effects fo progesterone, placebo and ibutilide will be assessed During the 7 days of treatment with progesterone/placebo and at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours after the ibutilide infusion
Primary Baseline (pre-ibutilide) QT-F and QT-Fram intervals QT intervals will be corrected for heart rate using two methods: the Fridericia method and the Framingham method After 7 days of treatment with oral progesterone or placebo, prior to receiving ibutilide
Primary Maximum post-ibutilide QT-F and QT-Fram intervals Maximum post-ibutilide QT-F and QT-Fram intervals Prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours after the ibutilide infusion
Primary % change from baseline (pre-ibutilide) in maximum QT-F and QT-Fram intervals % change from baseline (pre-ibutilide) in maximum QT-F and QT-Fram intervals Prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours after the ibutilide infusion
Primary Area under the QT-F and QT-Fram versus time curves during and for 1 hour following ibutilide infusion Area under the QT-F and QT-Fram versus time curves during and for 1 hour Prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1 hour after the ibutilide infusion
Primary Area under the QT-F and QT-Fram versus time curves during and for 8 hours following ibutilide infusion Area under the QT-F and QT-Fram versus time curves during and for 8 hours following ibutilide infusion Prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours after the ibutilide infusion
Secondary Baseline (pre-ibutilide) heart rate-corrected J-Tpeak (J-Tpeakc) intervals Baseline (pre-ibutilide) heart rate-corrected J-Tpeak (J-Tpeakc) intervals After 7 days of treatment with oral progesterone or placebo, prior to receiving ibutilide
Secondary Maximum post-ibutilide J-Tpeakc intervals Maximum post-ibutilide J-Tpeakc intervals Prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours after the ibutilide infusion
Secondary % change from baseline (pre-ibutilide) in maximum J-Tpeakc intervals % change from baseline (pre-ibutilide) in maximum J-Tpeakc intervals Prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours after the ibutilide infusion
Secondary Area under the J-Tpeakc versus time curve during and for 1 hour following ibutilide infusion Area under the J-Tpeakc versus time curve during and for 1 hour following Prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1 hour after the ibutilide infusion
Secondary Area under the J-Tpeakc versus time curve during and for 8 hours following ibutilide infusion Area under the J-Tpeakc versus time curve during and for 8 hours following Prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours after the ibutilide infusion
Secondary Baseline (pre-ibutilide) Tpeak-Tend intervals Baseline (pre-ibutilide) Tpeak-Tend intervals After 7 days of treatment with oral progesterone or placebo, prior to receiving ibutilide
Secondary Maximum post-ibutilide Tpeak-Tend intervals Maximum post-ibutilide Tpeak-Tend intervals Prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours after the ibutilide infusion
Secondary % change from baseline (pre-ibutilide) maximum Tpeak-Tend intervals % change from baseline (pre-ibutilide) maximum Tpeak-Tend intervals Prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours after the ibutilide infusion
Secondary Area under the Tpeak-Tend versus time curves during and for 1 hour following ibutilide infusion Area under the Tpeak-Tend versus time curves during and for 1 hour following ibutilide infusion Prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1 hour after the ibutilide infusion
Secondary Area under the Tpeak-Tend versus time curves during and for 8 hours following ibutilide infusion Area under the Tpeak-Tend versus time curves during and for 8 hours following ibutilide infusion Prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours after the ibutilide infusion
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