Long QT SyndromePhase 4NCT04675788
Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening
A Phase 4 study testing Progesterone, Ibutilide and Testosterone in people with Long QT Syndrome and Abnormalities, Drug-Induced, run by Indiana University at 3 sites in United States.
Trial summary
This research will determine if: 1) Oral progesterone attenuates drug-induced QT interval, J-Tpeak and Tpeak-Tend lengthening in postmenopausal women 50 years of age or older, and 2) Transdermal testosterone attenuates drug-induced QT interval, J-Tpeak and Tpeak-Tend lengthening in men 65 years of age or older. Read more about this study
- Who is it for?
- Ages 50 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Long QT Syndrome, Abnormalities, Drug-Induced
- What is being tested?
- Progesterone, Ibutilide and Testosterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Sep 2021to 16 Apr 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal Women:
- Age 50-99 years old
- Postmenopausal (have not has a menstrual period for 12 months or longer)
- Older Men:
- Age 65 years old to 99 years old
Who cannot join
- Postmenopausal women:
- Subject reported history of breast, uterine and ovarian cervical cancer
- Subject reported history of hysterectomy and/or ovariectomy
- Subject reported taking any hormone replacement therapy (prescription, nonprescription or herbal supplement)
- Weight < 60 kg at time of screening visit
- Weight >135 kg at time of screening visit
Show all 42Show fewer
- Serum K+ <3.6 mEq/L at time of any ibutilide dosing visit
- Serum Mg2+ <1.8 mg/dL at time of screening visit
- Hematocrit <26%
- AST or ALT > 3x the upper limit of normal (determined by testing lab ranges) at the time of screening visit
- Baseline Bazett's-corrected QTc >450 ms (during any visit prior to ibutilide dosing)
- Baseline QRS > 120 ms (at time of baseline visit)
- Diagnosis of heart failure due to reduced or preserved ejection fraction
- Subject reported family history of long QT syndrome, TdP, or sudden cardiac death not associated with acute myocardial infarction
- Self-reported personal history of long QT syndrome, sudden cardiac death not associated with acute myocardial infarction
- Subject reported history any prolonged arrhythmia for which treatment was required
- Subject reported history of a myocardial infarction
- Subject reported history of coronary artery disease
- Sustained arrythmia found at baseline screening prior to any study visit including atrial fibrillation, atrial flutter, junctional rhythm, heart block (any)
- Permanently paced ventricular rhythm
- Current reported use of any QT prolonging medication. Investigator will check the current QT drugs list at www.crediblemeds.org during screening.
- Current reported use of any moderate or strong inhibitors of cytochrome P450 (CYP) 3A4, 3A5, or 3A7
- Current reported use of any inducers of cytochrome P-450 (CYP) 3A4, 3A5 or 3A7
- Older men:
- Subject reported diagnosis of benign prostatic hyperplasia
- Subject reported history of breast or prostate cancer
- Weight < 60 kg at time of screening visit
- Weight >135 kg at time of screening visit
- Serum K+ <3.6 mEq/L at time of any ibutilide dosing visit
- Serum Mg2+ <1.8 mg/dL at time of screening visit
- Hematocrit <26%
- AST or ALT > 3x the upper limit of normal (determined by testing lab ranges) at the time of screening visit
- Baseline Bazett's-corrected QTc >450 ms (during any visit prior to ibutilide dosing)
- Baseline QRS > 120 ms (at time of baseline visit)
- Diagnosis of heart failure due to reduced or preserved ejection fraction
- Subject reported family history of long QT syndrome, TdP, or sudden cardiac death not associated with acute myocardial infarction
- Self-reported personal history of long QT syndrome, arrhythmias (including atrial fibrillation) or sudden cardiac death not associated with acute myocardial infarction
- Sustained arrythmia found at baseline screening prior to any study visit including atrial fibrillation, atrial flutter, junctional rhythm, heart block (any)
- Permanently paced ventricular rhythm
- Current reported use of any QT prolonging medication (Investigator will check current list of QT prolonging medications listed at www.crediblemeds.org at the time of screening for the most up to date list.
- Current reported use of any moderate or strong inhibitors of cytochrome P450 (CYP) 3A
- Current reported use of any inducers of cytochrome P-450 (CYP) 3A4, 3A5 or 3A7
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Indiana Clinical Research Center
Indianapolis, Indiana, 46202
Indiana University
Indianapolis, Indiana, 46202
Purdue University
Indianapolis, Indiana, 46202
About this study
This research will determine if: 1) Oral progesterone attenuates drug-induced QT interval, J-Tpeak and Tpeak-Tend lengthening in postmenopausal women 50 years of age or older, and 2) Transdermal testosterone attenuates drug-induced QT interval, J-Tpeak and Tpeak-Tend lengthening in men 65 years of age or older. This investigation will consist of two concurrent prospective, randomized, double-blind, placebo-controlled crossover-design studies in a) Postmenopausal women, and b) Men 65 years of age or older. Study 1: Each postmenopausal woman will take progesterone or placebo capsules for 1 week. After a 14-day "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. Study 2: Each man 65 years of age or older will apply transdermal testosterone or transdermal placebo gel for 3 days. After a 7-day "washout" (no testosterone or placebo) each subject will then apply the alternative therapy (testosterone or placebo gel) for 1 week. After 3 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 testosterone and placebo phases will be compared.
Read the detailed description
Torsades de pointes (TdP) is a ventricular tachycardia associated with prolongation of the corrected QT (QTc) interval, and which may be caused by > 150 widely used drugs. TdP results in catastrophic outcomes, including sudden cardiac death. Older age is a risk factor for drug-induced TdP, possibly due to declining serum progesterone and testosterone concentrations in postmenopausal women and men, respectively. The ECG biomarkers J-Tpeak and Tpeak-Tend, represent early and late repolarization, respectively, as well as dispersion of repolarization (Tpeak-Tend). Preclinical evidence and preliminary data from our group indicate that progesterone and testosterone exert protective effects against drug-induced prolongation of ventricular repolarization. Effective means of reducing the risk of drug-induced QTc interval prolongation and TdP in high risk populations requiring therapy with QTc-prolonging drugs have not been identified, and the effects of sex hormones on early vs late ventricular repolarization and dispersion of repolarization are unknown. The objectives of this research are to evaluate novel therapeutic approaches to attenuate drug-induced QTc lengthening. Our central hypothesis is that drug-induced QTc lengthening is attenuated by administration of oral progesterone and transdermal testosterone. Specific Aim 1: Determine the efficacy of oral progesterone as a preventive method to attenuate drug-induced QTc interval lengthening in postmenopausal women. Specific Aim 2: Determine the efficacy of transdermal testosterone as a preventive method to attenuate drug-induced QTc interval lengthening in men ≥ 65 years of age. Specific Aim 3a: Determine the influence of oral progesterone on drug-induced lengthening of early and late ventricular repolarization in postmenopausal women. Specific Aim 3b: Determine the influence of transdermal testosterone on drug-induced lengthening of early and late ventricular repolarization in men ≥ 65 years of age. Specific Aims 1\&3a will be achieved via a prospective, randomized, double-blind, placebo-controlled two-way crossover study in postmenopausal women age ≥ 50 years (n=48). Each subject will take oral progesterone 400 mg or matching placebo daily for 7 days (≥ 14-day washout period between phases). On day 7, each subject will receive a single dose of the QTc-lengthening drug ibutilide 0.003 mg/kg. Specific Aims 2\&3b will be achieved via a prospective, randomized, double-blind, placebo-controlled two-way crossover study in men ≥ 65 years of age (n=35). Each subject will apply transdermal testosterone 1% 100 mg or transdermal placebo once daily for 3 days (≥ 7-day washout period between phases). On day 7, each subject will ibutilide 0.003 mg/kg. In both studies, post-ibutilide QT, J-Tpeak and Tpeak-Tend intervals and serum ibutilide concentrations will be determined serially. Primary outcome measures: 1) Maximum post-ibutilide QTc intervals, 2) Maximum post-ibutilide % change in QTc intervals, 3) Area under the QTc interval-time curves, and 4) J-Tpeak and Tpeak-Tend intervals. This research will identify effective approaches for reducing the risk of drug-induced QTc interval prolongation in high-risk patients.
- Conditions
- Long QT Syndrome, Abnormalities, Drug-Induced
- Being tested
- Progesterone, Ibutilide, Testosterone, Placebo
- Medical subject headings
- Long QT Syndrome, Abnormalities, Drug-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days
IbutilideDrug
Also called Corvert
Ibutilide 0.003 mg/kg administered to all subjects to modestly lengthen the QT interval
TestosteroneDrug
Also called Androgel
Subjects will apply transdermal testosterone gel once daily every morning for 3 days
PlaceboDrug
Lactose capsules
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Progesterone; Drug: Ibutilide |
| Postmenopausal women: Placebo | Placebo comparator | Subjects will receive oral placebo, two capsules once daily every evening for 7 days Receives: Drug: Ibutilide; Drug: Placebo |
| Men 65 years of age or older: Testosterone | Experimental | Subjects will receive treatment with transdermal testosterone 1% (100 mg) every morning for 3 days Receives: Drug: Ibutilide; Drug: Testosterone |
| Men 65 years of age or older: Placebo | Placebo comparator | Subjects will receive treatment with transdermal placebo every morning for 3 days Receives: Drug: Ibutilide; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Morning of day 8 (after 7 days of progesterone/placebo)
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
Measured: Morning of day 4 (after 3 days of testosterone/placebo)
Maximum post-ibutilide QT-F and QT-Fram intervals
Maximum post-ibutilide QT-F and QT-Fram intervals
Measured: From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion
Percent change from baseline (pre-ibutilide) in maximum QT-F and QT-Fram intervals
Percent change from baseline (pre-ibutilide) in maximum QT-F and QT-Fram intervals
Measured: From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion
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
Measured: From initiation of ibutilide infusion and for 1 hour after the end of ibutilide infusion
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
Measured: From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion
Pre-ibutilide heart rate-corrected J-Tpeak (J-Tpeakc) intervals
Pre-ibutilide heart rate-corrected J-Tpeak (J-Tpeakc) intervals
Measured: Morning of day 8 (after 7 days of progesterone/placebo)
Pre-ibutilide heart rate-corrected J-Tpeak (J-Tpeakc) intervals
Pre-ibutilide heart rate-corrected J-Tpeak (J-Tpeakc) intervals
Measured: Morning of day 4 (after 3 days of testosterone/placebo)
Maximum post-ibutilide J-Tpeakc intervals
Maximum post-ibutilide J-Tpeakc intervals
Measured: From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion
Percent change from baseline (pre-ibutilide) in maximum J-Tpeakc intervals
Percent change from baseline (pre-ibutilide) in maximum J-Tpeakc intervals
Measured: From initiation of ibutilide infusion and for 8 hours after the end of 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 ibutilide infusion
Measured: From initiation of ibutilide infusion and for 1 hour after the end of ibutilide infusion
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 ibutilide infusion
Measured: From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion
Pre-ibutilide Tpeak-Tend intervals
Pre-ibutilide Tpeak-Tend intervals
Measured: Morning of day 8 (after 7 days of progesterone/placebo)
Pre-ibutilide Tpeak-Tend intervals
Pre-ibutilide Tpeak-Tend intervals
Measured: Morning of day 4 (after 3 days of testosterone/placebo)
Maximum post-ibutilide Tpeak-Tend intervals
Maximum post-ibutilide Tpeak-Tend intervals
Measured: From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion
Percent change from baseline (pre-ibutilide) maximum Tpeak-Tend intervals
Percent change from baseline (pre-ibutilide) maximum Tpeak-Tend intervals
Measured: From initiation of ibutilide infusion and for 8 hours after the end of 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
Measured: From initiation of ibutilide infusion and for 1 hour after the end of ibutilide infusion
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
Measured: From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start2 Sep 2021
- Primary completion16 Apr 2025
- Study completion16 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long QT SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Purdue University, National Heart, Lung, and Blood Institute (NHLBI), Harvard University, Cedars-Sinai Medical Center
- Responsible party
- Principal investigator, James E. Tisdale, Indiana University
- Investigators
- James E Tisdale, PharmD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675788
- Sponsor's protocol ID
- 2005890134
- Other IDs
- 1R01HL153114-01
- Status last verified
- Mar 2026
- First submitted
- 4 Dec 2020
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening
- ClinicalTrials.gov ID
- NCT04675788
- Acronym / sponsor ID
- 2005890134
- Conditions
- Long QT Syndrome, Abnormalities, Drug-Induced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Purdue University, National Heart, Lung, and Blood Institute (NHLBI), Harvard University, Cedars-Sinai Medical Center
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 16 Apr 2025 (actual)
- Study completion
- 16 Apr 2025 (actual)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research will determine if: 1) Oral progesterone attenuates drug-induced QT interval, J-Tpeak and Tpeak-Tend lengthening in postmenopausal women 50 years of age or older, and 2) Transdermal testosterone attenuates drug-induced QT interval, J-Tpeak and Tpeak-Tend lengthening in men 65 years of age or older. This investigation will consist of two concurrent prospective, randomized, double-blind, placebo-controlled crossover-design studies in a) Postmenopausal women, and b) Men 65 years of age or older. Study 1: Each postmenopausal woman will take progesterone or placebo capsules for 1 week. After a 14-day "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. Study 2: Each man 65 years of age or older will apply transdermal testosterone or transdermal placebo gel for 3 days. After a 7-day "washout" (no testosterone or placebo) each subject will then apply the alternative therapy (testosterone or placebo gel) for 1 week. After 3 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 testosterone and placebo phases will be compared.
Detailed description
Torsades de pointes (TdP) is a ventricular tachycardia associated with prolongation of the corrected QT (QTc) interval, and which may be caused by > 150 widely used drugs. TdP results in catastrophic outcomes, including sudden cardiac death. Older age is a risk factor for drug-induced TdP, possibly due to declining serum progesterone and testosterone concentrations in postmenopausal women and men, respectively. The ECG biomarkers J-Tpeak and Tpeak-Tend, represent early and late repolarization, respectively, as well as dispersion of repolarization (Tpeak-Tend). Preclinical evidence and preliminary data from our group indicate that progesterone and testosterone exert protective effects against drug-induced prolongation of ventricular repolarization. Effective means of reducing the risk of drug-induced QTc interval prolongation and TdP in high risk populations requiring therapy with QTc-prolonging drugs have not been identified, and the effects of sex hormones on early vs late ventricular repolarization and dispersion of repolarization are unknown. The objectives of this research are to evaluate novel therapeutic approaches to attenuate drug-induced QTc lengthening. Our central hypothesis is that drug-induced QTc lengthening is attenuated by administration of oral progesterone and transdermal testosterone. Specific Aim 1: Determine the efficacy of oral progesterone as a preventive method to attenuate drug-induced QTc interval lengthening in postmenopausal women. Specific Aim 2: Determine the efficacy of transdermal testosterone as a preventive method to attenuate drug-induced QTc interval lengthening in men ≥ 65 years of age. Specific Aim 3a: Determine the influence of oral progesterone on drug-induced lengthening of early and late ventricular repolarization in postmenopausal women. Specific Aim 3b: Determine the influence of transdermal testosterone on drug-induced lengthening of early and late ventricular repolarization in men ≥ 65 years of age. Specific Aims 1\&3a will be achieved via a prospective, randomized, double-blind, placebo-controlled two-way crossover study in postmenopausal women age ≥ 50 years (n=48). Each subject will take oral progesterone 400 mg or matching placebo daily for 7 days (≥ 14-day washout period between phases). On day 7, each subject will receive a single dose of the QTc-lengthening drug ibutilide 0.003 mg/kg. Specific Aims 2\&3b will be achieved via a prospective, randomized, double-blind, placebo-controlled two-way crossover study in men ≥ 65 years of age (n=35). Each subject will apply transdermal testosterone 1% 100 mg or transdermal placebo once daily for 3 days (≥ 7-day washout period between phases). On day 7, each subject will ibutilide 0.003 mg/kg. In both studies, post-ibutilide QT, J-Tpeak and Tpeak-Tend intervals and serum ibutilide concentrations will be determined serially. Primary outcome measures: 1) Maximum post-ibutilide QTc intervals, 2) Maximum post-ibutilide % change in QTc intervals, 3) Area under the QTc interval-time curves, and 4) J-Tpeak and Tpeak-Tend intervals. This research will identify effective approaches for reducing the risk of drug-induced QTc interval prolongation in high-risk patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Postmenopausal women: Progesterone | Experimental | Drug: Progesterone, Drug: IbutilideSubjects 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 | Drug: Ibutilide, Drug: PlaceboSubjects will receive oral placebo, two capsules once daily every evening for 7 days |
| Men 65 years of age or older: Testosterone | Experimental | Drug: Ibutilide, Drug: TestosteroneSubjects will receive treatment with transdermal testosterone 1% (100 mg) every morning for 3 days |
| Men 65 years of age or older: Placebo | Placebo comparator | Drug: Ibutilide, Drug: PlaceboSubjects will receive treatment with transdermal placebo every morning for 3 days |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 50-99 years old
- Postmenopausal (have not has a menstrual period for 12 months or longer)
- Age 65 years old to 99 years old
Key exclusion criteria (42 listed)
- Subject reported history of breast, uterine and ovarian cervical cancer
- Subject reported history of hysterectomy and/or ovariectomy
- Subject reported taking any hormone replacement therapy (prescription, nonprescription or herbal supplement)
- Weight < 60 kg at time of screening visit
- Weight >135 kg at time of screening visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProgesteroneSubjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days | Drug | Postmenopausal women: Progesterone |
| IbutilideAlso: CorvertIbutilide 0.003 mg/kg administered to all subjects to modestly lengthen the QT interval | Drug | Men 65 years of age or older: Placebo, Men 65 years of age or older: Testosterone, Postmenopausal women: Placebo, Postmenopausal women: Progesterone |
| TestosteroneAlso: AndrogelSubjects will apply transdermal testosterone gel once daily every morning for 3 days | Drug | Men 65 years of age or older: Testosterone |
| PlaceboLactose capsules | Drug | Men 65 years of age or older: Placebo, Postmenopausal women: Placebo |
Primary outcome
Pre-ibutilide QT-F and QT-Fram intervals
Time frame: Morning of day 8 (after 7 days of progesterone/placebo)
QT intervals will be corrected for heart rate using two methods: the Fridericia method and the Framingham method
Pre-ibutilide QT-F and QT-Fram intervals
Time frame: Morning of day 4 (after 3 days of testosterone/placebo)
QT intervals will be corrected for heart rate using two methods: the Fridericia method and the Framingham method
Maximum post-ibutilide QT-F and QT-Fram intervals
Time frame: From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion
Maximum post-ibutilide QT-F and QT-Fram intervals
Percent change from baseline (pre-ibutilide) in maximum QT-F and QT-Fram intervals
Time frame: From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion
Percent change from baseline (pre-ibutilide) in maximum QT-F and QT-Fram intervals
Area under the QT-F and QT-Fram versus time curves during and for 1 hour following ibutilide infusion
Time frame: From initiation of ibutilide infusion and for 1 hour after the end of ibutilide infusion
Area under the QT-F and QT-Fram versus time curves during and for 1 hour
Area under the QT-F and QT-Fram versus time curves during and for 8 hours following ibutilide infusion
Time frame: From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion
Area under the QT-F and QT-Fram versus time curves during and for 8 hours following ibutilide infusion
Pre-ibutilide heart rate-corrected J-Tpeak (J-Tpeakc) intervals
Time frame: Morning of day 8 (after 7 days of progesterone/placebo)
Pre-ibutilide heart rate-corrected J-Tpeak (J-Tpeakc) intervals
Pre-ibutilide heart rate-corrected J-Tpeak (J-Tpeakc) intervals
Time frame: Morning of day 4 (after 3 days of testosterone/placebo)
Pre-ibutilide heart rate-corrected J-Tpeak (J-Tpeakc) intervals
Maximum post-ibutilide J-Tpeakc intervals
Time frame: From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion
Maximum post-ibutilide J-Tpeakc intervals
Percent change from baseline (pre-ibutilide) in maximum J-Tpeakc intervals
Time frame: From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion
Percent change from baseline (pre-ibutilide) in maximum J-Tpeakc intervals
Area under the J-Tpeakc versus time curve during and for 1 hour following ibutilide infusion
Time frame: From initiation of ibutilide infusion and for 1 hour after the end of 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 8 hours following ibutilide infusion
Time frame: From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion
Area under the J-Tpeakc versus time curve during and for 8 hours following ibutilide infusion
Pre-ibutilide Tpeak-Tend intervals
Time frame: Morning of day 8 (after 7 days of progesterone/placebo)
Pre-ibutilide Tpeak-Tend intervals
Pre-ibutilide Tpeak-Tend intervals
Time frame: Morning of day 4 (after 3 days of testosterone/placebo)
Pre-ibutilide Tpeak-Tend intervals
Maximum post-ibutilide Tpeak-Tend intervals
Time frame: From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion
Maximum post-ibutilide Tpeak-Tend intervals
Percent change from baseline (pre-ibutilide) maximum Tpeak-Tend intervals
Time frame: From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion
Percent change from baseline (pre-ibutilide) maximum Tpeak-Tend intervals
Area under the Tpeak-Tend versus time curves during and for 1 hour following ibutilide infusion
Time frame: From initiation of ibutilide infusion and for 1 hour after the end of 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 8 hours following ibutilide infusion
Time frame: From initiation of ibutilide infusion and for 8 hours after the end of ibutilide infusion
Area under the Tpeak-Tend versus time curves during and for 8 hours following ibutilide infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James E Tisdale, PharmD principal investigator
Purdue University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Progesterone, Ibutilide and Testosterone in people with Long QT Syndrome and Abnormalities, Drug-Induced, run by Indiana University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-ibutilide QT-F and QT-Fram intervals (time frame: Morning of day 8 (after 7 days of progesterone/placebo)). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.