Assessing the Safety/Efficacy of Transdermal Testosterone in Female Patients With Symptomatic Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: placebo; testosterone
Intervention description: placebo patch; 300 or 450 micrograms/day transdermal testosterone patch
Intervention MeSH terms: Testosterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: Female
Minimum age: 50 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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)