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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.
Age
50 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Research Site
Phoenix, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Lakewood, California, United States
Research Site
Riverside, California, United States
Research Site
Stamford, Connecticut, United States
Research Site
Melbourne, Florida, United States
Research Site
Pensacola, Florida, United States
Research Site
Savannah, Georgia, United States
Research Site
Munster, Indiana, United States
Research Site
Brooklyn, New York, United States
Start Date
July 1, 2009
Primary Completion Date
April 1, 2010
Completion Date
May 1, 2010
Last Updated
January 13, 2012
17
ACTUAL participants
placebo
DRUG
testosterone
DRUG
Lead Sponsor
Warner Chilcott
NCT07484009
NCT07191730
Data Source & Attribution
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