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| Name | Class |
|---|---|
| American Heart Association | OTHER |
| Purdue University | OTHER |
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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
Torsades de pointes (TdP) is a catastrophic arrhythmia associated with corrected QT (QTc) interval prolongation, which can be induced by > 150 commonly prescribed drugs. TdP risk is higher in women and is modulated by the ratio of serum progesterone and estradiol; the higher the serum progesterone and progesterone:estradiol ratio, the lower the risk, and vice-versa. TdP risk increases with age, likely due to declining postmenopausal progesterone concentrations. Methods to reduce TdP risk in postmenopausal women requiring therapy with QTc interval-prolonging drugs have not been developed. In addition, the differential effects of progesterone on drug-induced lengthening of early vs late ventricular repolarization in humans are unknown. The investigators have previously shown that oral progesterone attenuates QTc interval lengthening in young women during the menses phase when serum estradiol concentrations are low. However, whether oral progesterone remains effective for attenuating drug-induced QTc interval lengthening during menstrual cycle phases with higher serum estradiol concentrations is unknown. The efficacy of oral progesterone for attenuating drug-induced QTc interval lengthening in postmenopausal women is also unknown. Specific Aim1: Determine the efficacy of oral progesterone as a preventive method to diminish drug-induced QTc interval lengthening in postmenopausal women. Specific Aim 2: Determine the influence of oral progesterone on drug-induced lengthening of early versus late ventricular repolarization in postmenopausal women. Specific Aim 3: Determine the efficacy of oral progesterone to diminish drug-induced QTc interval lengthening in premenopausal women during the ovulation phase of the menstrual cycle, when serum estradiol concentrations are high. Specific Aim 4: Specific Aim 4: Determine the influence of oral progesterone on drug-induced lengthening of early versus late ventricular repolarization in premenopausal women during the ovulation phase of the menstrual cycle, when serum estradiol concentrations are high.
Concurrent prospective, randomized, double-blind, placebo-controlled two-way crossover-design studies will be conducted in a) Postmenopausal women > 50 years of age (n=20) and b) Premenopausal women 21-40 years of age (n=20) who will be studied during the ovulation phase of the menstural cycle. QTc interval response to low-dose ibutilide will be assessed. Subjects will receive, in randomized order (with a minimum two-week washout phase) oral progesterone 400 mg or placebo once daily for 7 days. On the morning after the 7th dose, subjects will present to the Indiana Clinical Research Center to receive one dose of the QT interval-lengthening drug ibutilide 0.003 mg/kg, after which ECGs and blood for determination of serum ibutilide concentrations will be obtained serially for 8 hours. Primary outcome measures: 1) Baseline (pre-ibutilide) Fridericia (QTFrid) and Framingham (QTFram)-corrected QT intervals, 2) Maximum QTFrid and QTFram intervals following ibutilide, 3) Maximum % change in QTFrid and QTFram intervals following ibutilide, 4) Area under the QTFrid and QTFram interval-time curves from 0-1 and 0-8 hours. Secondary outcome measures: 1) J-Tpeak interval, 2) Tpeak-Tend interval, and 5) Incidence of progesterone and ibutilide adverse effects. These studies will establish oral progesterone as a safe and effective method of attenuating drug-induced QTc interval lengthening in postmenopausal women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postmenopausal women: Progesterone | Experimental | Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days |
|
| Postmenopausal women: Placebo | Placebo Comparator | Subjects will receive oral placebo, two capsules once daily every evening for 7 days |
|
| Premenopausal women: Progesterone | Experimental | Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days |
|
| Premenopausal women: Placebo | Placebo Comparator | Subjects will receive oral placebo, two capsules once daily every evening for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progesterone | Drug | Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline (Pre-ibutilide) QT-F Intervals | QT intervals will be corrected for heart rate using the Fridericia method | After 7 days of treatment with oral progesterone or placebo, prior to receiving ibutilide |
| Maximum Post-ibutilide QT-F Intervals | Maximum post-ibutilide QT-F 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 |
| % Change From Baseline (Pre-ibutilide) in Maximum QT-F Intervals | % change from baseline (pre-ibutilide) in maximum QT-F 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 |
| Area Under the QT-F Versus Time Curves During and for 1 Hour Following Ibutilide Infusion | Area under the QT-F 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Maximum Post-ibutilide J-Tpeakc Intervals |
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Inclusion Criteria:
Postmenopausal women:
Premenopausal women:
- 21-40 years of age
Exclusion Criteria:
History of breast, uterine or ovarian cancer
History of hysterectomy and/or ovariectomy
Weight > 135 kg
Serum K+ < 3.6 mEq/L;
Serum Mg2+ < 1.8 mg/dL;
Hematocrit < 26%;
Hepatic transaminases > 3x upper limit of normal;
Baseline Bazett's-corrected QT interval > 450 ms
Taking hormone replacement therapy
Diagnosis of heart failure
Symptoms associated with heart failure:
Current ECG rhythm of atrial fibrillation or other tachyarrhythmia
Family or personal history of long-QT syndrome or sudden cardiac death not associated with acute myocardial infarction
Concomitant use of any QTc interval-prolonging drug.
Permanently paced ventricular rhythm
Pregnancy
Using any hormonal contraceptives [oral contraceptives, hormone-secreting intrauterine devices (IUDs), hormonal implants]
Postmenopausal - 50 years of age or older and no menstrual period for 365 days or longer
Premenopausal - 21-40 years of age
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| Name | Affiliation | Role |
|---|---|---|
| James E Tisdale, PharmD | Purdue University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | United States |
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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
Participants recruited from a) Indiana CTSI ALL IN for Health Research database, and b) advertisements on the Indiana University-Indianapolis and Purdue University campuses
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Treatment |
| |||||||||||||
| Second Treatment |
|
Premenopausal women: 18 participants were enrolled. Two participants were excluded from the outcome measures analysis because they did not complete all treatment phases (n=2). Thus 16 participants composed the final sample size for analysis of outcome measures. For analysis of adverse events, 18 participants received progesterone, and 16 participants received placebo; 16 participants received Ibutilide during the progesterone phase and 16 participants received ibutilide during placebo phase.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 median 41-day washout period, participants received oral placebo, two capsules once daily every evening for 7 days. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Baseline (Pre-ibutilide) QT-F Intervals | QT intervals will be corrected for heart rate using the Fridericia method | Posted | Mean | Standard Deviation | ms | After 7 days of treatment with oral progesterone or placebo, prior to receiving ibutilide |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Premenopausal Women: Progesterone | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue/malaise | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James E. Tisdale, PharmD | Purdue University | 317-880-5418 | jtisdale@purdue.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 31, 2020 | May 21, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008133 | Long QT Syndrome |
| D000014 | Abnormalities, Drug-Induced |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
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| ID | Term |
|---|---|
| D011374 | Progesterone |
| C067192 | ibutilide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Ibutilide | Drug | Ibutilide 0.003 mg/kg administered to all subjects to moderately lengthen the QT interval |
|
|
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 |
| % 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 |
| 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 |
| 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 |
| 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 |
| % 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 |
| 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Premenopausal Women - Placebo Then Progesterone |
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. |
| BG002 | 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 washout period of at least two weeks, participants received oral placebo, two capsules once daily every evening for 7 days. |
| BG003 | Postmenopausal Women - Placebo Then Progesterone | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Postmenopausal Women: Progesterone | 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 |
| OG003 | Postmenopausal Women: Placebo | 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 |
|
|
|
| Primary | Maximum Post-ibutilide QT-F Intervals | Maximum post-ibutilide QT-F intervals | Posted | Mean | Standard Deviation | ms | 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 Intervals | % change from baseline (pre-ibutilide) in maximum QT-F intervals | Posted | Mean | Standard Deviation | % change from baseline value | 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 Versus Time Curves During and for 1 Hour Following Ibutilide Infusion | Area under the QT-F versus time curves during and for 1 hour | Posted | Mean | Standard Deviation | ms*hr | 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 | Baseline (Pre-ibutilide) Heart Rate-corrected J-Tpeak (J-Tpeakc) Intervals | Baseline (pre-ibutilide) heart rate-corrected J-Tpeak (J-Tpeakc) intervals | Posted | Mean | Standard Deviation | ms | After 7 days of treatment with oral progesterone or placebo, prior to receiving ibutilide |
|
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|
|
| Secondary | Maximum Post-ibutilide J-Tpeakc Intervals | Maximum post-ibutilide J-Tpeakc intervals | Posted | Mean | Standard Deviation | ms | 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 | Posted | Mean | Standard Deviation | % change from baseline value | 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 | Posted | Mean | Standard Deviation | ms*hr | 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 |
|
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|
|
| Secondary | Baseline (Pre-ibutilide) Tpeak-Tend Intervals | Baseline (pre-ibutilide) Tpeak-Tend intervals | Posted | Mean | Standard Deviation | ms | After 7 days of treatment with oral progesterone or placebo, prior to receiving ibutilide |
|
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|
| Secondary | Maximum Post-ibutilide Tpeak-Tend Intervals | Maximum post-ibutilide Tpeak-Tend intervals | Posted | Mean | Standard Deviation | ms | 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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|
|
| Secondary | % Change From Baseline (Pre-ibutilide) Maximum Tpeak-Tend Intervals | % change from baseline (pre-ibutilide) maximum Tpeak-Tend intervals | Posted | Mean | Standard Deviation | % change from baseline value | 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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| 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 | Posted | Mean | Standard Deviation | ms*hr | 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 |
|
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|
| 0 |
| 18 |
| 0 |
| 18 |
| 11 |
| 18 |
| EG001 | Premenopausal Women: Placebo | 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 | 0 | 16 | 0 | 16 | 2 | 16 |
| EG002 | Postmenopausal Women: Progesterone | 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 | 0 | 7 | 0 | 7 | 4 | 7 |
| EG003 | Postmenopausal Women: Placebo | 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 | 0 | 7 | 0 | 7 | 0 | 7 |
| Spotting | Reproductive system and breast disorders | Systematic Assessment |
|
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| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |