Indianapolis, Indiana 46202


Purpose:

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 individually-corrected QT interval (QTcI) response to ibutilide, in the presence and absence of testosterone, and in the presence or absence of progesterone: 1) Effect on pre-ibutilide QTcI, 2) Effect on maximum post-ibutilide QTcI, 3) Effect on % change in post-ibutilide QTcI, and 2) Area under the QTcI interval-time curves.


Criteria:

Inclusion Criteria: - Men ≥ 65 years of age Exclusion Criteria: - Prostate cancer; history of prostate cancer; - History of breast cancer; benign prostatic hypertrophy; - Weight < 60 kg - Weight > 135 kg - Serum k+ < 3.6 mEq/L; - Serum mg2+ < 1.8 mg/dL; - Hemoglobin < 9.0 mg/dL; - Hematocrit < 26%; - Hepatic transaminases > 3x upper limit of normal; - Baseline Bazett's-corrected QT interval > 450 ms - Heart failure due to reduced ejection fraction (left ventricular ejection fraction < 40%) - Family or personal history of long-QT syndrome, arrhythmias or sudden cardiac death; - Concomitant use of any QT interval-prolonging drug.


NCT ID:

NCT02513940


Primary Contact:

James Tisdale, PharmD
Phone: 317-880-5418
Email: jtisdale@purdue.edu


Backup Contact:

Email: hwroblew@iu.edu
Heather Jaynes, MSN
Phone: 317-880-5410


Location Contact:

Indianapolis, Indiana 46202
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

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