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

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.

Inclusion Criteria:

• Female 50 years of age or older; post-menopausal (≥ 12 Mo/ from last menstruation)
• Documented left ventricular ejection fraction (LVEF) of 20-40% within 90 days prior to the baseline visit
• History of HF for more than 90 days and a diagnosis of symptomatic HF (Class III NYHA) for at least 30 days prior to the baseline visit
• Ambulatory (i.e., able to walk without assistance of another person or device such as cane or walker)

Exclusion Criteria:

• Neuromuscular or rheumatologic conditions that limit the to their ability to improve walking distance
• Pulmonary edema or multiorgan failure or cardiogenic shock within 30 days prior to the baseline visit
• Congenital heart disease, infiltrative myocardial disease
• Unstable angina or myocardial infarction within 30 days prior to the baseline visit
• Undiagnosed abnormal genital bleeding
• History of breast cancer, breast surgery, or breast disease contraindicating estrogen/hormone therapy
• Polycystic ovary syndrome or any other condition known to be adversely affected by testosterone treatment
• Resting heart rate > 120 bpm
• Systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg
• Known or suspected hypersensitivity or allergy to any adhesive or to any of the components of the testosterone transdermal system (TTS)
• Use of SERMS, SARMS, SPRMs, tibolone, testosterone, estrogen, progesterone agonists and antagonists or taking any prescription and over the counter medications/ nutraceuticals (eg, phyto-estrogens) that may have anabolic or steroid hormonal effects within 30 days prior to the baseline visit
• Use of marketed or investigational oral, sub-lingual, topical, transdermal injectable, or vaginal androgen therapy including dehydroepiandrosterone (DHEA) at any time within 3 months prior to the baseline visit
• Use of systemic corticosteroids within 30 days prior to the baseline visit (acute use for fewer than 7 days is acceptable)