Hormone shield: could progesterone or testosterone guard against Drug-Induced heart risks?
NCT ID NCT04675788
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether taking progesterone (in women) or testosterone (in men) could reduce dangerous changes in heart rhythm caused by certain medications. 73 healthy older adults (postmenopausal women and men 65+) took either the hormone or a placebo, then received a small dose of a heart-rhythm-altering drug. Researchers measured heart electrical activity to see if the hormones offered protection. The goal was to find new ways to prevent drug-induced heart problems.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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73 people
The number who actually took part.
- Started
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Sep 2021
- Finished
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Apr 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Postmenopausal Women: * Age 50-99 years old * Postmenopausal (have not has a menstrual period for 12 months or longer) Exclusion Criteria: 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 * 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 Inclusion Criteria: Older Men: • Age 65 years old to 99 years old Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Indiana Clinical Research Center
Indianapolis, Indiana, 46202, United States
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Indiana University
Indianapolis, Indiana, 46202, United States
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Purdue University
Indianapolis, Indiana, 46202, United States
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