Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT00957034
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)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
50 Years
Study:
NCT00957034
Study Brief:
Protocol Section:
NCT00957034