Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy ResponSE in Hypogonadal Men (TRAVERSE) Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5,246
- 试验地点
- 384
- 主要终点
- Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event
研究概览
简要总结
This is a double-blinded and placebo-controlled study of topical testosterone replacement therapy (TRT) in symptomatic hypogonadal men with pre-existing cardiovascular disease (CVD) or increased risk for CVD.
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
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men between 45 and 80 years age
- •Participants with low serum testosterone concentrations (< 300 ng/dL) who exhibit at least one sign or symptom of hypogonadism and have evidence of cardiovascular (CV) disease or are at an increased risk for CV disease.
排除标准
- •Participants with congenital or acquired hypogonadism for whom long-term therapy with placebo would not be medically appropriate
- •Participants with prostate specific antigen (PSA) > 3.0 ng/mL (or 1.5 if on 5-alpha reductase inhibitors)
- •Participants who have been treated with testosterone in the past 6 months and for whom testosterone therapy is contraindicated
- •Confirmed testosterone < 100 ng/dL
- •Body Mass Index (BMI) > 50
- •Hemoglobin A1c (HbA1C) > 11%
- •Hematocrit (Hct) > 50%
- •Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min
- •History of deep vein thrombosis or pulmonary embolism or prostate cancer or heart failure (Class III and IV).
研究组 & 干预措施
AndroGel 1.62%
Participants receive topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug once daily (OD). Participants may receive a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations are necessary.
干预措施: AndroGel® (Drug)
Placebo
Participants receive matching placebo OD.
干预措施: Placebo (Drug)
结局指标
主要结局
Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event
时间窗: Randomization to event or last known date if no event (up to approximately 52 months)
MACE is a composite endpoint including non-fatal myocardial infraction (MI), non-fatal stroke and cardiovascular (CV) death as adjudicated by Clinical Events Committee (CEC).
Time From Randomization to the First Component Event of MACE
时间窗: Randomization to event or last known date if no event (up to approximately 52 months)
MACE is a composite endpoint including non-fatal MI, non-fatal stroke and CV death as adjudicated by CEC.
次要结局
- Incidence of High-Grade Prostate Cancer(Randomization to event or last known date if no event (up to approximately 52 months).)
- Time From Randomization to the First Component Event of CV Safety Endpoint: Number and Percentage of Participants With an Event(Randomization to event or last known date if no event (up to approximately 52 months).)
- Time From Randomization to the First Component Event of CV Safety Endpoint(Randomization to event or last known date if no event (up to approximately 52 months).)