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NCT02513940 · ClinicalTrials.gov registry record · Phase 4
Influence of Testosterone Administration on Drug-Induced QT Interval Prolongation and Torsades de Pointes
A Phase 4 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 4
- Development phase
- 14
- Enrollment target
NCT02513940 is a Phase 4 study that has completed, run by Indiana University. The registered enrollment target is 14 participants.
The verdict
NCT02513940, a Phase 4 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 14 participants
- Enrollment target
Study Summary
Torsades de pointes (TdP) is a potentially fatal ventricular arrhythmia associated with corrected QT (QTc) interval prolongation. More than 50 commonly used drugs available on the US market may cause QTc interval prolongation and TdP. While TdP occurs more commonly in women, 33-45% of all cases of TdP have occurred in men. Older age is a risk factor for drug-induced TdP in men, possibly due to declining serum testosterone concentrations. Available evidence shows an inverse relationship between QTc intervals and serum testosterone concentrations. In addition, experimental data, including those from the investigators' laboratory, suggest that both exogenous testosterone or progesterone administration may be protective against prolongation of ventricular repolarization and TdP. Specific Aim: Establish the influence of transdermal testosterone administration and oral progesterone administration as preventive methods by which to diminish the degree of drug-induced QT interval prolongation in men 65 years of age or older. Hypothesis: Transdermal testosterone administration and oral progesterone administration both effectively attenuate drug-induced QT interval response in older men. To test this hypothesis, transdermal testosterone, oral progesterone or placebo will be administered in a 3-way crossover study to men 65 years of age or older. QTc interval response to low-dose ibutilide will be assessed. The primary endpoints will be Fridericia-corrected QT interval (QTF) response to ibutilide, in the presence and absence of testosterone, and in the presence or absence of progesterone: 1) Effect on pre-ibutilide QTF, 2) Effect on maximum post-ibutilide QTF, 3) Effect on % change in post-ibutilide QTF, and 2) Area under the QTF interval-time curves.
Interventions
- DRUG Placebo
- DRUG Progesterone
- DRUG Testosterone
- DRUG Ibutilide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2016-05 |
| Est. Completion | 2017-10-19 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02513940
The ClinicalTrials.gov registry entry for NCT02513940 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02513940 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02513940 about?
NCT02513940 is a clinical study titled "Influence of Testosterone Administration on Drug-Induced QT Interval Prolongation and Torsades de Pointes". Torsades de pointes (TdP) is a potentially fatal ventricular arrhythmia associated with corrected QT (QTc) interval prolongation. More than 50 commonly used drugs available on the US market may cause QTc interval prolongation and TdP. While TdP occurs more commonly in women, 33-45% of all cases of T...
What is the current status of trial NCT02513940?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2016-05. Estimated completion is 2017-10-19.
What interventions are being tested in trial NCT02513940?
The interventions under investigation include: Placebo (DRUG), Progesterone (DRUG), Testosterone (DRUG), Ibutilide (DRUG).
Who is sponsoring clinical trial NCT02513940?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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