Heart Failure Clinical Trial
Official title:
A Placebo-controlled Study to Determine the Efficacy and Safety of 300 and 450 µg/Day Transdermal Testosterone in Female Patients With Low Ejection Fraction and Symptomatic Heart Failure
Heart failure (HF) is a complex condition resulting from structural or functional heart
diseases that impair the ability of the heart to fill with or pump out blood. The main
manifestations of HF are shortness of breath and tiredness which may limit the ability to
exercise or perform simple daily physical activities such as walking. Heart disease leading
to HF is associated with reduced muscle mass and reduced strength and low blood levels of
testosterone; a hormone normally produced by the human (male and female) body. Recent
studies have shown improvements of symptoms and ability to exercise in patients with heart
failure receiving testosterone.
This is a placebo controlled study to determine the efficacy and safety of low dose
testosterone (300 and 450 microgram/day) delivered by a transdermal system (patch) in women
with significant HF.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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