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Assessing the Safety/Efficacy of Transdermal Testosterone in Female Patients With Symptomatic Heart Failure

2014-07-23 21:13:40 | BioPortfolio

Summary

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Heart Failure

Intervention

placebo, 300 µg/day testosterone, 450 µg/day testosterone

Location

Research Site
Phoenix
Arizona
United States
85253

Status

Terminated

Source

Warner Chilcott

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:13:40-0400

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Steroidal compounds related to TESTOSTERONE, the major mammalian male sex hormone. Testosterone congeners include important testosterone precursors in the biosynthetic pathways, metabolites, derivatives, and synthetic steroids with androgenic activities.

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