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

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)