Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening: Reducing the Risk of Drug-Induced QT Interval Lengthening in Women

Investigation of Progesterone for Reducing Drug-Induced Changes in Heart's Electrical Activity

Recruiting
21 years - 100 years
Female
Phase N/A
1 Location

Brief description of study.

The purpose of this study is to determine the effectiveness of progesterone given by mouth for minimizing drug EKG response to a drug.

Detailed description of study

Our objective is to evaluate and compare the efficacy of novel therapeutic approaches to reduce the risk of drug-induced QTc interval prolongation and TdP.
Participants will be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: healthy,Torsades de pointes,menopause
  • Age: 21 years - 100 years
  • Gender: Female

Inclusion Criteria
Postmenopausal women, based on the following criteria:
Age 50 years of age or older AND

No menstrual periods for 365 days or longer
 
Premenopausal women:
21-40 years of age
 

Exclusion Criteria
History of breast, ovarian or uterine cancer
Taking hormone replacement therapy
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
Permanently paced ventricular rhythm

Updated on 19 Feb 2024. Study ID: 1806935117

This study investigates the use of progesterone, a hormone given by mouth, to see if it can reduce the response of the heart's electrical activity to a specific drug. The study focuses on preventing changes in the heart's rhythm that can be caused by some medications, specifically looking at the QTc interval, which is a measure of the heart's electrical cycle.

Participants in this study will take part in procedures that include receiving either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine. The study aims to compare the effects of progesterone with other therapeutic approaches to see which is more effective in reducing the risk of heart rhythm changes.

  • Who can participate: The study is open to postmenopausal women aged 50 or older who have not had menstrual periods for at least 365 days, as well as premenopausal women aged 21-40. Participants should not have a history of certain cancers or heart conditions, and should not be taking hormone replacement therapy or medications that affect the heart's rhythm.
  • Study details: Participants will receive either the investigational medication or a placebo. Participants will follow study procedures to evaluate the effects on heart rhythm changes.

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