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 |
|