Trial Outcomes & Findings for Reducing the Risk of Drug-Induced QT Interval Lengthening in Women (NCT NCT03834883)
NCT ID: NCT03834883
Last Updated: 2025-07-01
Results Overview
QT intervals will be corrected for heart rate using the Fridericia method
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
27 participants
Primary outcome timeframe
After 7 days of treatment with oral progesterone or placebo, prior to receiving ibutilide
Results posted on
2025-07-01
Participant Flow
Participants recruited from a) Indiana CTSI ALL IN for Health Research database, and b) advertisements on the Indiana University-Indianapolis and Purdue University campuses
Premenopausal women: n=222 participants assessed for eligibility; n=20 consented, n=202 excluded (n=50 did not meet inclusion criteria, n=152); n=18 enrolled Postmenopausal women: Target sample size n=16. Did not achieve target because of delays/problems due to COVID-19 and limited budget. n=22 were assessed for eligibility; n=12 consented; 3 excluded because QTc \> 450 ms; 9 enrolled; 2 dropped out in pandemic, completed 1 phase
Participant milestones
| Measure |
Premenopausal Women: Progesterone Then Placebo
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days. After a two-week washout period, participants received oral placebo, two capsules once daily every evening for 7 days.
|
Premenopausal Women: Placebo Then Progesterone
Participants received oral placebo, two capsules once daily every evening for 7 days. After a two-week washout period, participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days.
|
Postmenopausal Women: Progesterone Then Placebo
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days. After a two-week washout period, participants received oral placebo, two capsules once daily every evening for 7 days.
|
Postmenopausal Women: Placebo Then Progesterone
Participants received oral placebo, two capsules once daily every evening for 7 days. After a two-week washout period, participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days.
|
|---|---|---|---|---|
|
First Treatment
STARTED
|
9
|
9
|
3
|
6
|
|
First Treatment
COMPLETED
|
9
|
9
|
3
|
6
|
|
First Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Treatment
STARTED
|
9
|
9
|
3
|
6
|
|
Second Treatment
COMPLETED
|
7
|
9
|
2
|
5
|
|
Second Treatment
NOT COMPLETED
|
2
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Premenopausal Women: Progesterone Then Placebo
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days. After a two-week washout period, participants received oral placebo, two capsules once daily every evening for 7 days.
|
Premenopausal Women: Placebo Then Progesterone
Participants received oral placebo, two capsules once daily every evening for 7 days. After a two-week washout period, participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days.
|
Postmenopausal Women: Progesterone Then Placebo
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days. After a two-week washout period, participants received oral placebo, two capsules once daily every evening for 7 days.
|
Postmenopausal Women: Placebo Then Progesterone
Participants received oral placebo, two capsules once daily every evening for 7 days. After a two-week washout period, participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days.
|
|---|---|---|---|---|
|
Second Treatment
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Second Treatment
COVID-19 pandemic
|
1
|
0
|
1
|
1
|
Baseline Characteristics
Reducing the Risk of Drug-Induced QT Interval Lengthening in Women
Baseline characteristics by cohort
| Measure |
Premenopausal Women - Progesterone Then Placebo
n=9 Participants
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days. After a median 41-day washout period, participants received oral placebo, two capsules once daily every evening for 7 days.
|
Premenopausal Women - Placebo Then Progesterone
n=9 Participants
Participants received oral placebo, two capsules once daily every evening for 7 days. After a median 41-day washout period, participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days.
|
Postmenopausal Women - Progesterone Then Placebo
n=3 Participants
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days. After a washout period of at least two weeks, participants received oral placebo, two capsules once daily every evening for 7 days.
|
Postmenopausal Women - Placebo Then Progesterone
n=6 Participants
Participants received oral placebo, two capsules once daily every evening for 7 days. After a washout period of at least two weeks, participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
29 years
STANDARD_DEVIATION 6 • n=5 Participants
|
29 years
STANDARD_DEVIATION 6 • n=7 Participants
|
65 years
STANDARD_DEVIATION 4 • n=5 Participants
|
64 years
STANDARD_DEVIATION 9 • n=4 Participants
|
47 years
STANDARD_DEVIATION 6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
27 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: After 7 days of treatment with oral progesterone or placebo, prior to receiving ibutilideQT intervals will be corrected for heart rate using the Fridericia method
Outcome measures
| Measure |
Premenopausal Women: Progesterone
n=16 Participants
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Participants received 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 participants to moderately lengthen the QT interval
|
Premenopausal Women: Placebo
n=16 Participants
Participants received oral placebo, two capsules once daily every evening for 7 days
Ibutilide: Ibutilide 0.003 mg/kg administered to all participants to moderately lengthen the QT interval
|
Postmenopausal Women: Progesterone
n=7 Participants
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Participants received 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 participants to moderately lengthen the QT interval
|
Postmenopausal Women: Placebo
n=7 Participants
Participants received oral placebo, two capsules once daily every evening for 7 days
Ibutilide: Ibutilide 0.003 mg/kg administered to all participants to moderately lengthen the QT interval
|
|---|---|---|---|---|
|
Baseline (Pre-ibutilide) QT-F Intervals
|
417 ms
Standard Deviation 11
|
421 ms
Standard Deviation 10
|
413 ms
Standard Deviation 21
|
414 ms
Standard Deviation 22
|
PRIMARY outcome
Timeframe: 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 infusionMaximum post-ibutilide QT-F intervals
Outcome measures
| Measure |
Premenopausal Women: Progesterone
n=16 Participants
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Participants received 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 participants to moderately lengthen the QT interval
|
Premenopausal Women: Placebo
n=16 Participants
Participants received oral placebo, two capsules once daily every evening for 7 days
Ibutilide: Ibutilide 0.003 mg/kg administered to all participants to moderately lengthen the QT interval
|
Postmenopausal Women: Progesterone
n=7 Participants
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Participants received 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 participants to moderately lengthen the QT interval
|
Postmenopausal Women: Placebo
n=7 Participants
Participants received oral placebo, two capsules once daily every evening for 7 days
Ibutilide: Ibutilide 0.003 mg/kg administered to all participants to moderately lengthen the QT interval
|
|---|---|---|---|---|
|
Maximum Post-ibutilide QT-F Intervals
|
465 ms
Standard Deviation 13
|
475 ms
Standard Deviation 9
|
450 ms
Standard Deviation 27
|
460 ms
Standard Deviation 28
|
PRIMARY outcome
Timeframe: 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% change from baseline (pre-ibutilide) in maximum QT-F intervals
Outcome measures
| Measure |
Premenopausal Women: Progesterone
n=16 Participants
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Participants received 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 participants to moderately lengthen the QT interval
|
Premenopausal Women: Placebo
n=16 Participants
Participants received oral placebo, two capsules once daily every evening for 7 days
Ibutilide: Ibutilide 0.003 mg/kg administered to all participants to moderately lengthen the QT interval
|
Postmenopausal Women: Progesterone
n=7 Participants
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Participants received 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 participants to moderately lengthen the QT interval
|
Postmenopausal Women: Placebo
n=7 Participants
Participants received oral placebo, two capsules once daily every evening for 7 days
Ibutilide: Ibutilide 0.003 mg/kg administered to all participants to moderately lengthen the QT interval
|
|---|---|---|---|---|
|
% Change From Baseline (Pre-ibutilide) in Maximum QT-F Intervals
|
11.3 % change from baseline value
Standard Deviation 2.2
|
12.4 % change from baseline value
Standard Deviation 2.5
|
9.2 % change from baseline value
Standard Deviation 1.3
|
11.0 % change from baseline value
Standard Deviation 3.0
|
PRIMARY outcome
Timeframe: 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 infusionArea under the QT-F versus time curves during and for 1 hour
Outcome measures
| Measure |
Premenopausal Women: Progesterone
n=16 Participants
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Participants received 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 participants to moderately lengthen the QT interval
|
Premenopausal Women: Placebo
n=16 Participants
Participants received oral placebo, two capsules once daily every evening for 7 days
Ibutilide: Ibutilide 0.003 mg/kg administered to all participants to moderately lengthen the QT interval
|
Postmenopausal Women: Progesterone
n=7 Participants
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Participants received 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 participants to moderately lengthen the QT interval
|
Postmenopausal Women: Placebo
n=7 Participants
Participants received oral placebo, two capsules once daily every evening for 7 days
Ibutilide: Ibutilide 0.003 mg/kg administered to all participants to moderately lengthen the QT interval
|
|---|---|---|---|---|
|
Area Under the QT-F Versus Time Curves During and for 1 Hour Following Ibutilide Infusion
|
500 ms*hr
Standard Deviation 13
|
510 ms*hr
Standard Deviation 9
|
480 ms*hr
Standard Deviation 33
|
510 ms*hr
Standard Deviation 28
|
SECONDARY outcome
Timeframe: After 7 days of treatment with oral progesterone or placebo, prior to receiving ibutilideBaseline (pre-ibutilide) heart rate-corrected J-Tpeak (J-Tpeakc) intervals
Outcome measures
| Measure |
Premenopausal Women: Progesterone
n=16 Participants
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Participants received 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 participants to moderately lengthen the QT interval
|
Premenopausal Women: Placebo
n=16 Participants
Participants received oral placebo, two capsules once daily every evening for 7 days
Ibutilide: Ibutilide 0.003 mg/kg administered to all participants to moderately lengthen the QT interval
|
Postmenopausal Women: Progesterone
n=7 Participants
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Participants received 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 participants to moderately lengthen the QT interval
|
Postmenopausal Women: Placebo
n=7 Participants
Participants received oral placebo, two capsules once daily every evening for 7 days
Ibutilide: Ibutilide 0.003 mg/kg administered to all participants to moderately lengthen the QT interval
|
|---|---|---|---|---|
|
Baseline (Pre-ibutilide) Heart Rate-corrected J-Tpeak (J-Tpeakc) Intervals
|
218 ms
Standard Deviation 25
|
221 ms
Standard Deviation 26
|
219 ms
Standard Deviation 10
|
219 ms
Standard Deviation 11
|
SECONDARY outcome
Timeframe: 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 infusionMaximum post-ibutilide J-Tpeakc intervals
Outcome measures
| Measure |
Premenopausal Women: Progesterone
n=16 Participants
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Participants received 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 participants to moderately lengthen the QT interval
|
Premenopausal Women: Placebo
n=16 Participants
Participants received oral placebo, two capsules once daily every evening for 7 days
Ibutilide: Ibutilide 0.003 mg/kg administered to all participants to moderately lengthen the QT interval
|
Postmenopausal Women: Progesterone
n=7 Participants
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Participants received 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 participants to moderately lengthen the QT interval
|
Postmenopausal Women: Placebo
n=7 Participants
Participants received oral placebo, two capsules once daily every evening for 7 days
Ibutilide: Ibutilide 0.003 mg/kg administered to all participants to moderately lengthen the QT interval
|
|---|---|---|---|---|
|
Maximum Post-ibutilide J-Tpeakc Intervals
|
230 ms
Standard Deviation 31
|
272 ms
Standard Deviation 28
|
234 ms
Standard Deviation 15
|
243 ms
Standard Deviation 13
|
SECONDARY outcome
Timeframe: 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% change from baseline (pre-ibutilide) in maximum J-Tpeakc intervals
Outcome measures
| Measure |
Premenopausal Women: Progesterone
n=16 Participants
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Participants received 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 participants to moderately lengthen the QT interval
|
Premenopausal Women: Placebo
n=16 Participants
Participants received oral placebo, two capsules once daily every evening for 7 days
Ibutilide: Ibutilide 0.003 mg/kg administered to all participants to moderately lengthen the QT interval
|
Postmenopausal Women: Progesterone
n=7 Participants
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Participants received 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 participants to moderately lengthen the QT interval
|
Postmenopausal Women: Placebo
n=7 Participants
Participants received oral placebo, two capsules once daily every evening for 7 days
Ibutilide: Ibutilide 0.003 mg/kg administered to all participants to moderately lengthen the QT interval
|
|---|---|---|---|---|
|
% Change From Baseline (Pre-ibutilide) in Maximum J-Tpeakc Intervals
|
11.7 % change from baseline value
Standard Deviation 5.8
|
14.1 % change from baseline value
Standard Deviation 5.8
|
6.1 % change from baseline value
Standard Deviation 3.5
|
7.9 % change from baseline value
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 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 infusionArea under the J-Tpeakc versus time curve during and for 1 hour following
Outcome measures
| Measure |
Premenopausal Women: Progesterone
n=16 Participants
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Participants received 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 participants to moderately lengthen the QT interval
|
Premenopausal Women: Placebo
n=16 Participants
Participants received oral placebo, two capsules once daily every evening for 7 days
Ibutilide: Ibutilide 0.003 mg/kg administered to all participants to moderately lengthen the QT interval
|
Postmenopausal Women: Progesterone
n=7 Participants
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Participants received 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 participants to moderately lengthen the QT interval
|
Postmenopausal Women: Placebo
n=7 Participants
Participants received oral placebo, two capsules once daily every evening for 7 days
Ibutilide: Ibutilide 0.003 mg/kg administered to all participants to moderately lengthen the QT interval
|
|---|---|---|---|---|
|
Area Under the J-Tpeakc Versus Time Curve During and for 1 Hour Following Ibutilide Infusion
|
248 ms*hr
Standard Deviation 42
|
276 ms*hr
Standard Deviation 40
|
258 ms*hr
Standard Deviation 13
|
261 ms*hr
Standard Deviation 14
|
SECONDARY outcome
Timeframe: After 7 days of treatment with oral progesterone or placebo, prior to receiving ibutilideBaseline (pre-ibutilide) Tpeak-Tend intervals
Outcome measures
| Measure |
Premenopausal Women: Progesterone
n=16 Participants
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Participants received 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 participants to moderately lengthen the QT interval
|
Premenopausal Women: Placebo
n=16 Participants
Participants received oral placebo, two capsules once daily every evening for 7 days
Ibutilide: Ibutilide 0.003 mg/kg administered to all participants to moderately lengthen the QT interval
|
Postmenopausal Women: Progesterone
n=7 Participants
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Participants received 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 participants to moderately lengthen the QT interval
|
Postmenopausal Women: Placebo
n=7 Participants
Participants received oral placebo, two capsules once daily every evening for 7 days
Ibutilide: Ibutilide 0.003 mg/kg administered to all participants to moderately lengthen the QT interval
|
|---|---|---|---|---|
|
Baseline (Pre-ibutilide) Tpeak-Tend Intervals
|
85 ms
Standard Deviation 6
|
88 ms
Standard Deviation 5
|
79 ms
Standard Deviation 8
|
80 ms
Standard Deviation 8
|
SECONDARY outcome
Timeframe: 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 infusionMaximum post-ibutilide Tpeak-Tend intervals
Outcome measures
| Measure |
Premenopausal Women: Progesterone
n=16 Participants
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Participants received 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 participants to moderately lengthen the QT interval
|
Premenopausal Women: Placebo
n=16 Participants
Participants received oral placebo, two capsules once daily every evening for 7 days
Ibutilide: Ibutilide 0.003 mg/kg administered to all participants to moderately lengthen the QT interval
|
Postmenopausal Women: Progesterone
n=7 Participants
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Participants received 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 participants to moderately lengthen the QT interval
|
Postmenopausal Women: Placebo
n=7 Participants
Participants received oral placebo, two capsules once daily every evening for 7 days
Ibutilide: Ibutilide 0.003 mg/kg administered to all participants to moderately lengthen the QT interval
|
|---|---|---|---|---|
|
Maximum Post-ibutilide Tpeak-Tend Intervals
|
99 ms
Standard Deviation 6
|
102 ms
Standard Deviation 5
|
81 ms
Standard Deviation 8
|
87 ms
Standard Deviation 9
|
SECONDARY outcome
Timeframe: 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% change from baseline (pre-ibutilide) maximum Tpeak-Tend intervals
Outcome measures
| Measure |
Premenopausal Women: Progesterone
n=16 Participants
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Participants received 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 participants to moderately lengthen the QT interval
|
Premenopausal Women: Placebo
n=16 Participants
Participants received oral placebo, two capsules once daily every evening for 7 days
Ibutilide: Ibutilide 0.003 mg/kg administered to all participants to moderately lengthen the QT interval
|
Postmenopausal Women: Progesterone
n=7 Participants
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Participants received 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 participants to moderately lengthen the QT interval
|
Postmenopausal Women: Placebo
n=7 Participants
Participants received oral placebo, two capsules once daily every evening for 7 days
Ibutilide: Ibutilide 0.003 mg/kg administered to all participants to moderately lengthen the QT interval
|
|---|---|---|---|---|
|
% Change From Baseline (Pre-ibutilide) Maximum Tpeak-Tend Intervals
|
16.1 % change from baseline value
Standard Deviation 5.6
|
16.0 % change from baseline value
Standard Deviation 5.2
|
8.8 % change from baseline value
Standard Deviation 3.6
|
10.5 % change from baseline value
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: 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 infusionArea under the Tpeak-Tend versus time curves during and for 1 hour following ibutilide infusion
Outcome measures
| Measure |
Premenopausal Women: Progesterone
n=16 Participants
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Participants received 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 participants to moderately lengthen the QT interval
|
Premenopausal Women: Placebo
n=16 Participants
Participants received oral placebo, two capsules once daily every evening for 7 days
Ibutilide: Ibutilide 0.003 mg/kg administered to all participants to moderately lengthen the QT interval
|
Postmenopausal Women: Progesterone
n=7 Participants
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Participants received 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 participants to moderately lengthen the QT interval
|
Postmenopausal Women: Placebo
n=7 Participants
Participants received oral placebo, two capsules once daily every evening for 7 days
Ibutilide: Ibutilide 0.003 mg/kg administered to all participants to moderately lengthen the QT interval
|
|---|---|---|---|---|
|
Area Under the Tpeak-Tend Versus Time Curves During and for 1 Hour Following Ibutilide Infusion
|
98 ms*hr
Standard Deviation 6
|
104 ms*hr
Standard Deviation 7
|
90 ms*hr
Standard Deviation 9
|
97 ms*hr
Standard Deviation 9
|
Adverse Events
Premenopausal Women: Progesterone
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Premenopausal Women: Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Postmenopausal Women: Progesterone
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Postmenopausal Women: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Premenopausal Women: Progesterone
n=18 participants at risk
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Participants received 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 participants to moderately lengthen the QT interval
|
Premenopausal Women: Placebo
n=16 participants at risk
Participants received oral placebo, two capsules once daily every evening for 7 days
Ibutilide: Ibutilide 0.003 mg/kg administered to all participants to moderately lengthen the QT interval
|
Postmenopausal Women: Progesterone
n=7 participants at risk
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Participants received 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 participants to moderately lengthen the QT interval
|
Postmenopausal Women: Placebo
n=7 participants at risk
Participants received treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Progesterone: Participants received 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 participants to moderately lengthen the QT interval
|
|---|---|---|---|---|
|
General disorders
Fatigue/malaise
|
38.9%
7/18 • Number of events 7 • Premenopausal women: During 7 days of therapy with progesterone and placebo, administered in randomized order, separated by a washout period. n=18 women completed the progesterone phase, n=16 women completed the placebo phase. Postmenopausal women: During 7 days of therapy with progesterone and placebo, administered in randomized order, separated by a washout period. n=7 women completed the progesterone phase, n=7 women completed the placebo phase.
|
12.5%
2/16 • Number of events 2 • Premenopausal women: During 7 days of therapy with progesterone and placebo, administered in randomized order, separated by a washout period. n=18 women completed the progesterone phase, n=16 women completed the placebo phase. Postmenopausal women: During 7 days of therapy with progesterone and placebo, administered in randomized order, separated by a washout period. n=7 women completed the progesterone phase, n=7 women completed the placebo phase.
|
57.1%
4/7 • Number of events 4 • Premenopausal women: During 7 days of therapy with progesterone and placebo, administered in randomized order, separated by a washout period. n=18 women completed the progesterone phase, n=16 women completed the placebo phase. Postmenopausal women: During 7 days of therapy with progesterone and placebo, administered in randomized order, separated by a washout period. n=7 women completed the progesterone phase, n=7 women completed the placebo phase.
|
0.00%
0/7 • Premenopausal women: During 7 days of therapy with progesterone and placebo, administered in randomized order, separated by a washout period. n=18 women completed the progesterone phase, n=16 women completed the placebo phase. Postmenopausal women: During 7 days of therapy with progesterone and placebo, administered in randomized order, separated by a washout period. n=7 women completed the progesterone phase, n=7 women completed the placebo phase.
|
|
Reproductive system and breast disorders
Spotting
|
22.2%
4/18 • Number of events 4 • Premenopausal women: During 7 days of therapy with progesterone and placebo, administered in randomized order, separated by a washout period. n=18 women completed the progesterone phase, n=16 women completed the placebo phase. Postmenopausal women: During 7 days of therapy with progesterone and placebo, administered in randomized order, separated by a washout period. n=7 women completed the progesterone phase, n=7 women completed the placebo phase.
|
0.00%
0/16 • Premenopausal women: During 7 days of therapy with progesterone and placebo, administered in randomized order, separated by a washout period. n=18 women completed the progesterone phase, n=16 women completed the placebo phase. Postmenopausal women: During 7 days of therapy with progesterone and placebo, administered in randomized order, separated by a washout period. n=7 women completed the progesterone phase, n=7 women completed the placebo phase.
|
0.00%
0/7 • Premenopausal women: During 7 days of therapy with progesterone and placebo, administered in randomized order, separated by a washout period. n=18 women completed the progesterone phase, n=16 women completed the placebo phase. Postmenopausal women: During 7 days of therapy with progesterone and placebo, administered in randomized order, separated by a washout period. n=7 women completed the progesterone phase, n=7 women completed the placebo phase.
|
0.00%
0/7 • Premenopausal women: During 7 days of therapy with progesterone and placebo, administered in randomized order, separated by a washout period. n=18 women completed the progesterone phase, n=16 women completed the placebo phase. Postmenopausal women: During 7 days of therapy with progesterone and placebo, administered in randomized order, separated by a washout period. n=7 women completed the progesterone phase, n=7 women completed the placebo phase.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place