Testosterone Regulation of the Natriuretic Peptide System
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Atrial natriuretic peptide levels
研究概览
简要总结
The proposed study is a physiologic investigation of the effects of testosterone on the natriuretic peptide system. The hypotheses of the study are that testosterone administration will decrease natriuretic peptide levels and salt excretion. The entire protocol is 8 weeks in duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men: aged 18 to 40 years, normal testosterone and free testosterone levels, no history of hypertension, and BMI between 18.5 and
- •Women: aged 18 to 40 years old, regular menstrual periods, negative pregnancy test, no oral contraceptives for ≥ 3 mos, no history of hypertension, BMI between 18.5 and 25.
排除标准
- •Antihypertensives, diuretics or insulin, diabetes mellitus, prior cardiovascular, abnormal liver or renal disease, history of cancer, atrial fibrillation, or abnormal sodium or potassium level.
研究组 & 干预措施
Testosterone
Testosterone cream applied daily
干预措施: Nesiritide (Drug)
Testosterone
Testosterone cream applied daily
干预措施: Testosterone (Drug)
Testosterone
Testosterone cream applied daily
干预措施: Leuprolide (Drug)
Testosterone
Testosterone cream applied daily
干预措施: Anastrozole (Drug)
Placebo
Identical placebo cream applied daily
干预措施: Nesiritide (Drug)
Placebo
Identical placebo cream applied daily
干预措施: Leuprolide (Drug)
Placebo
Identical placebo cream applied daily
干预措施: Anastrozole (Drug)
Placebo
Identical placebo cream applied daily
干预措施: Placebo (Drug)
结局指标
主要结局
Atrial natriuretic peptide levels
时间窗: 8 weeks
次要结局
- Urinary salt excretion(8 weeks)
研究者
Karen Klahr Miller, MD
Director, Neuroendocrine Research Program in Women's Health
Massachusetts General Hospital