Status:
TERMINATED
Assessing the Safety/Efficacy of Transdermal Testosterone in Female Patients With Symptomatic Heart Failure
Lead Sponsor:
Warner Chilcott
Conditions:
Heart Failure
Eligibility:
FEMALE
50+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00957034
Start Date
July 1 2009
End Date
May 1 2010
Last Update
January 13 2012
Active Locations (16)
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1
Research Site
Phoenix, Arizona, United States, 85253
2
Research Site
Tucson, Arizona, United States, 85710
3
Research Site
Lakewood, California, United States, 90712
4
Research Site
Riverside, California, United States, 92501