NCT00957034

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	placebo	placebo patch
DRUG	testosterone	300 or 450 micrograms/day transdermal testosterone patch

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-04-01
• Completion: 2010-05-01
• First posted: 2009-08-12
• Last updated: 2012-01-13
• Results posted: 2012-01-13

Locations

16 sites across 1 country: United States