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Hormone shield: could progesterone or testosterone guard against Drug-Induced heart risks?

NCT ID NCT04675788

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

73 people

The number who actually took part.

Started

Sep 2021

Finished

Apr 2025

Lead sponsor

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

50 to 99 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Indiana Clinical Research Center

    Indianapolis, Indiana, 46202, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Purdue University

    Indianapolis, Indiana, 46202, United States

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