NCT00082186已完成4 期
TRACLEER® (Bosentan) Pulmonary Arterial Hypertension A Multicenter, Open-label, Single-arm Safety Study to Investigate the Effects of Chronic TRACLEER® Treatment on Testicular Function in Male Patients With Pulmonary Arterial Hypertension
Actelion0 个研究点目标入组 22 人开始时间: 2003年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 主要终点
- Proportion of patients with a mean decrease in sperm concentration to 7.5 x 10[6]/mL or below, without a single sperm concentration ≥ 20 x 10[6]/mL, at 3 or 6 months. This proportion is considered of clinical relevance if greater than 30%.
研究概览
简要总结
The objective of the study is to evaluate the effects of chronic TRACLEER® treatment on testicular function via semen analysis in male patients with primary pulmonary arterial hypertension (PAH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients age 18-65 years.
- •Bosentan-naïve.
- •PPH, WHO functional class III/IV, in need of TRACLEER
- •Patients pulmonary arterial hypertension (PAH) secondary to congenital heart disease.
- •Written informed consent.
排除标准
- •Patients with PAH secondary to connective tissue vascular diseases or HIV.
- •Patients who have undergone a vasectomy.
- •Patients with an average baseline sperm concentration < 15 x 10[6]/mL, or any sample with a sperm concentration <= 7.5 x 10[6]/mL.
- •Patients with an average baseline sperm motility <20% or normal sperm morphology <5%.
- •Body weight < 50 kg.
- •Hypotension, defined as systolic blood pressure less than 85 mm Hg.
- •AST and/or ALT plasma levels greater than 3 times ULN.
- •Hypersensitivity to bosentan or any of the components of the formulation.
- •Treatment with glyburide, cyclosporine A or tacrolimus at inclusion or planned during the study.
- •Treatment with hormone suppressive agents, including androgens, estrogens, anabolic steroids or glucocorticoids within the past 6 months or planned during the study.
- •Current treatment less than 3 months prior to inclusion or planned treatment with prostacyclin or prostacyclin analogues (e.g., Flolanâ or Remodulin).
- •Patients who received an investigational drug in the month preceding the study start or who are due to be treated with another investigational drug during the study period.
- •Known drug or alcohol dependence or any other factors that will interfere with conduct of the study.
- •Any illness other than PPH that will reduce life expectancy to less than 6 months.
- •Active cancer.
- •Prior treatment with an anti-neoplastic agent or ionizing radiation.
- •Hot tub/Jacuzzi use.
- •Uncontrolled diseases including diabetes, liver or kidney disease.
- •Patients receiving spironolactone (aldactone) less than 3 months prior to inclusion or dose >25 mg/day at baseline or anytime during the study.
研究组 & 干预措施
1
Experimental
Oral bosentan tablets
干预措施: bosentan (Drug)
结局指标
主要结局
Proportion of patients with a mean decrease in sperm concentration to 7.5 x 10[6]/mL or below, without a single sperm concentration ≥ 20 x 10[6]/mL, at 3 or 6 months. This proportion is considered of clinical relevance if greater than 30%.
时间窗: From baseline to end of study.
次要结局
- Semen volume, sperm motility and sperm morphology change(From baseline to 3 & 6 months)
研究者
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