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Progesterone + Testosterone for Long QT Syndrome

Phase 4
Recruiting
Led By James E Tisdale, PharmD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Postmenopausal (have not had a menstrual period for 12 months or longer)
Postmenopausal Women: Age 50-99 years old
Must not have
Older men: Baseline Bazett's-corrected QTc >450 ms (during any visit prior to ibutilide dosing)
Older men: Diagnosis of heart failure due to reduced or preserved ejection fraction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up adverse effects will be assessed via telephone calls to subjects between days 2 and 4 and between days 5 and 7 of oral progesterone and oral placebo
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will study the effects of progesterone and testosterone on QT interval lengthening in postmenopausal women and men over 65.

Who is the study for?
This trial is for postmenopausal women aged 50-99 and men aged 65-99 without certain health conditions like severe anemia, heart issues, or a history of specific cancers. Participants should not be on hormone replacement therapy or drugs that affect heart rhythm.
What is being tested?
The study tests if progesterone in women and testosterone in men can reduce changes to the heart's electrical activity caused by ibutilide, a drug known to lengthen the QT interval. It's a controlled experiment where participants randomly receive either the hormone treatment or placebo.
What are the potential side effects?
Possible side effects include hormonal changes such as mood swings or weight gain for both treatments. Ibutilide may cause cardiac arrhythmias, which are irregularities in heartbeat rhythm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not had a menstrual period for at least 12 months.
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I am a woman aged 50-99 and have gone through menopause.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My heart's electrical activity reading (QTc) is over 450 ms.
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I am an older man diagnosed with heart failure.
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I am a postmenopausal woman and have had heart rhythm problems that needed treatment.
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I am a postmenopausal woman who has had a heart attack.
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I am a man with a history of heart rhythm problems not caused by a heart attack.
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I am a postmenopausal woman diagnosed with heart failure.
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I am a postmenopausal woman and I am currently taking medication that strongly affects liver enzymes.
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I am currently using medication that affects liver enzymes.
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I am a postmenopausal woman with a history of long QT syndrome or sudden cardiac death not due to a heart attack.
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I am currently using medication that strongly affects liver enzyme activity.
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I am a postmenopausal woman weighing more than 135 kg.
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I am a postmenopausal woman with a hematocrit level below 26%.
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My potassium level is below 3.6 mEq/L before taking ibutilide.
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I am a man weighing less than 60 kg at the time of screening.
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I have been diagnosed with an enlarged prostate.
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My heart's electrical activity takes longer than normal.
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I am a man with a family history of sudden heart issues not caused by a heart attack.
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My heart rhythm is controlled by a pacemaker.
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I am a postmenopausal woman with a family history of sudden heart issues not related to a heart attack.
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My magnesium level is below 1.8 mg/dL.
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I am a postmenopausal woman and I am taking hormone replacement therapy.
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I am a postmenopausal woman with a history of breast, uterine, or ovarian cancer.
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I am a postmenopausal woman weighing less than 60 kg.
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I am a man with a history of breast or prostate cancer.
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I am a postmenopausal woman with a history of heart disease.
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I am a postmenopausal woman with liver enzyme levels more than three times the normal limit.
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I am a postmenopausal woman and I am currently taking medication that can affect my heart's rhythm.
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I am a postmenopausal woman with a permanent pacemaker.
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My blood's hematocrit level is below 26%.
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I am a postmenopausal woman who has had a hysterectomy or ovariectomy.
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I am a man weighing more than 135 kg.
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I have a heart rhythm problem detected before starting the study.
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My liver enzymes are more than three times the normal limit.
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I am a postmenopausal woman with a QTc over 450 ms.
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I am a postmenopausal woman with a QRS duration over 120 ms.
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I am a postmenopausal woman with a history of irregular heart rhythms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~adverse effects will be assessed via telephone calls to subjects between days 2 and 4 and between days 5 and 7 of oral progesterone and oral placebo
This trial's timeline: 3 weeks for screening, Varies for treatment, and adverse effects will be assessed via telephone calls to subjects between days 2 and 4 and between days 5 and 7 of oral progesterone and oral placebo for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
Area under the QT-F and QT-Fram versus time curves during and for 1 hour following ibutilide infusion
+12 more
Other study objectives
Adverse effects of ibutilide
Adverse effects of oral progesterone and placebo
Adverse effects of transdermal testosterone and transdermal placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Postmenopausal women: ProgesteroneExperimental Treatment2 Interventions
Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Group II: Men 65 years of age or older: TestosteroneExperimental Treatment2 Interventions
Subjects will receive treatment with transdermal testosterone 1% (100 mg) every morning for 3 days
Group III: Men 65 years of age or older: PlaceboPlacebo Group2 Interventions
Subjects will receive treatment with transdermal placebo every morning for 3 days
Group IV: Postmenopausal women: PlaceboPlacebo Group2 Interventions
Subjects will receive oral placebo, two capsules once daily every evening for 7 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Progesterone
2013
Completed Phase 4
~4510
Ibutilide
2013
Completed Phase 4
~250
Testosterone
2009
Completed Phase 4
~2020

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,921 Previous Clinical Trials
47,760,539 Total Patients Enrolled
8 Trials studying Long QT Syndrome
7,763 Patients Enrolled for Long QT Syndrome
Harvard UniversityOTHER
233 Previous Clinical Trials
473,848 Total Patients Enrolled
Cedars-Sinai Medical CenterOTHER
509 Previous Clinical Trials
162,596 Total Patients Enrolled

Media Library

Placebo (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04675788 — Phase 4
Long QT Syndrome Research Study Groups: Men 65 years of age or older: Testosterone, Men 65 years of age or older: Placebo, Postmenopausal women: Progesterone, Postmenopausal women: Placebo
Long QT Syndrome Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04675788 — Phase 4
Placebo (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04675788 — Phase 4
~4 spots leftby Dec 2024
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