Reducing the Risk of Drug-Induced QT Interval Lengthening in Women
Long QT Syndrome, Abnormalities, Drug-Induced
About this trial
This is an interventional prevention trial for Long QT Syndrome
Eligibility Criteria
Inclusion Criteria:
Postmenopausal women:
- 50 years of age or older
- No menstrual periods for 365 days or longer
Premenopausal women:
- 21-40 years of age
Exclusion Criteria:
- History of breast, uterine or ovarian cancer
- History of hysterectomy and/or ovariectomy
- Weight > 135 kg
- Serum K+ < 3.6 mEq/L;
- Serum Mg2+ < 1.8 mg/dL;
- Hematocrit < 26%;
- Hepatic transaminases > 3x upper limit of normal;
- Baseline Bazett's-corrected QT interval > 450 ms
- Taking hormone replacement therapy
- Diagnosis of heart failure
Symptoms associated with heart failure:
- Pitting edema > 2+
- Crackles or rales on lung auscultation
- S3 or S4 heart sounds
- Unable to climb at least 2 flights of stairs without becoming short of breath
- Current ECG rhythm of atrial fibrillation or other tachyarrhythmia
- Family or personal history of long-QT syndrome or sudden cardiac death not associated with acute myocardial infarction
- Concomitant use of any QTc interval-prolonging drug.
- Permanently paced ventricular rhythm
- Pregnancy
- Using any hormonal contraceptives [oral contraceptives, hormone-secreting intrauterine devices (IUDs), hormonal implants]
Sites / Locations
- Indiana UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Postmenopausal women: Progesterone
Postmenopausal women: Placebo
Premenopausal women: Progesterone
Premenopausal women: Placebo
Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Subjects will receive oral placebo, two capsules once daily every evening for 7 days
Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Subjects will receive oral placebo, two capsules once daily every evening for 7 days