Long QT SyndromePhase 4NCT03834883
Reducing the Risk of Drug-Induced QT Interval Lengthening in Women
A Phase 4 study testing Progesterone and Ibutilide in people with Long QT Syndrome and Abnormalities, Drug-Induced, run by Indiana University at 1 site in United States.
Trial summary
This research will determine if oral progesterone attenuates drug-induced QT interval lengthening in a) Postmenopausal women 50 years of age or older, and b) Premenopausal women studied during the ovulation phase of the menstrual cycle. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Long QT Syndrome, Abnormalities, Drug-Induced
- What is being tested?
- Progesterone and Ibutilide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2019to 23 May 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women:
- 50 years of age or older
- No menstrual periods for 365 days or longer
- Premenopausal women:
- 21-40 years of age
Who cannot join
- 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%;
Show all 21Show fewer
- 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:
- Pitting edema > 2+
- Crackles or rales on lung auscultation
- S3 or S4 heart sounds
- Unable to climb at least 2 flights of stairs without becoming short of breath
- 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]
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening: Reducing the Risk of Drug-Induced QT Interval Lengthening in Women
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
Read the detailed description
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.
- Conditions
- Long QT Syndrome, Abnormalities, Drug-Induced
- Being tested
- Progesterone, Ibutilide
- 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 moderately lengthen the QT interval
| 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 |
| 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 Receives: Drug: Progesterone; Drug: Ibutilide |
| Premenopausal women: Placebo | Placebo comparator | Subjects will receive oral placebo, two capsules once daily every evening for 7 days Receives: Drug: Ibutilide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline (Pre-ibutilide) QT-F Intervals
QT intervals will be corrected for heart rate using the Fridericia method
Measured: 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
Measured: 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
Measured: 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
Measured: 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 outcomes (8)
Baseline (Pre-ibutilide) Heart Rate-corrected J-Tpeak (J-Tpeakc) Intervals
Baseline (pre-ibutilide) heart rate-corrected J-Tpeak (J-Tpeakc) intervals
Measured: After 7 days of treatment with oral progesterone or placebo, prior to receiving ibutilide
Maximum Post-ibutilide J-Tpeakc Intervals
Maximum post-ibutilide J-Tpeakc intervals
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start26 Mar 2019
- Primary completion21 May 2024
- Study completion23 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Long QT SyndromeStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, Purdue University
- 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
- NCT03834883
- Sponsor's protocol ID
- 1806935117
- Status last verified
- Jun 2025
- First submitted
- 6 Feb 2019
- Last updated
- 1 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening: Reducing the Risk of Drug-Induced QT Interval Lengthening in Women
- ClinicalTrials.gov ID
- NCT03834883
- Acronym / sponsor ID
- 1806935117
- Conditions
- Long QT Syndrome, Abnormalities, Drug-Induced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- American Heart Association, Purdue University
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 8 Feb 2019 (actual)
- Results
- Posted 1 Jul 2025
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 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
Detailed description
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.
Study design
- Primary purpose
- Prevention
- 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: IbutilideSubjects will receive oral placebo, two capsules once daily every evening for 7 days |
| Premenopausal 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 |
| Premenopausal women: Placebo | Placebo comparator | Drug: IbutilideSubjects will receive oral placebo, two capsules once daily every evening for 7 days |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 50 years of age or older
- No menstrual periods for 365 days or longer
- 21-40 years of age
Key exclusion criteria (21 listed)
- 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;
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, Premenopausal women: Progesterone |
| IbutilideAlso: CorvertIbutilide 0.003 mg/kg administered to all subjects to moderately lengthen the QT interval | Drug | Postmenopausal women: Placebo, Postmenopausal women: Progesterone, Premenopausal women: Placebo, Premenopausal women: Progesterone |
Primary outcome
Baseline (Pre-ibutilide) QT-F Intervals
Time frame: After 7 days of treatment with oral progesterone or placebo, prior to receiving ibutilide
QT intervals will be corrected for heart rate using the Fridericia method
Maximum Post-ibutilide QT-F Intervals
Time frame: 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
Maximum post-ibutilide QT-F intervals
% Change From Baseline (Pre-ibutilide) in Maximum QT-F Intervals
Time frame: 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
Area Under the QT-F Versus Time Curves During and for 1 Hour Following Ibutilide Infusion
Time frame: 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
Area under the QT-F versus time curves during and for 1 hour
8 secondary outcomes
Baseline (Pre-ibutilide) Heart Rate-corrected J-Tpeak (J-Tpeakc) Intervals
Time frame: After 7 days of treatment with oral progesterone or placebo, prior to receiving ibutilide
Maximum Post-ibutilide J-Tpeakc Intervals
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: After 7 days of treatment with oral progesterone or placebo, prior to receiving ibutilide
Maximum Post-ibutilide Tpeak-Tend Intervals
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
1 site 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 and Ibutilide in people with Long QT Syndrome and Abnormalities, Drug-Induced, run by Indiana University at 1 site 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 21 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 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 1 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Baseline (Pre-ibutilide) QT-F Intervals (time frame: After 7 days of treatment with oral progesterone or placebo, prior to receiving ibutilide). The study lists 4 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 1 Jul 2025.