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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in Six Minute Walking Test (6MWT), Meters
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
placebo
placebo patch
干预措施: placebo (Drug)
300 µg/day testosterone
300 micrograms/day transdermal testosterone patch
干预措施: testosterone (Drug)
450 µg/day testosterone
450 micrograms/day transdermal testosterone patch
干预措施: testosterone (Drug)
结局指标
主要结局
Percent Change From Baseline in Six Minute Walking Test (6MWT), Meters
时间窗: Baseline and Day 180
Measurement of distance walked as fast as possible on a hard flat pathway in six minutes
次要结局
- Percent Change From Baseline in Severity of Heart Failure (HF) as Measured by New York Heart Association (NYHA) Classification(Baseline and Day 180)
- Mortality or Hospitalizations(Baseline and Day 180)
- Percent Change Minnesota Living With Heart Failure Questionnaire (MLHFQ) Overall Score and Domain Scores(Baseline and Day 180)
- Percent Change Patient Global Assessment of Heart Failure Status(Baseline and Day 180)
- Percent Change Physician Global Assessment of Heart Failure Status(Baseline and Day 180)