Intratesticular Hormone Levels in Healthy Young Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Intratesticular Hormones in Normal Men
研究概览
简要总结
The purpose of this investigational study is to find out what hormones are present in healthy male testicles using fine needle aspiration.
详细描述
We will collect a very small amount of fluid from each testicle. Participation will last up to 12 weeks. The study involves a minimum of 4 visits, the screening visit and procedure Day, fine needle aspiration of the testes (about 1-1.5 hours each) and two follow-up visits (about 30-45 minutes). Over the course of the study, you will have a little less than a 1/3-cup of blood drawn (roughly 2-3 tablespoons at each visit).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •males between 18 and 50 years of age
- •sperm count greater than 20 million/ml, greater than 50% motility, and greater than 15% normal morphology
- •in good general health based on normal screening evaluation (consisting of a medical history, physical exam, normal sperm count, normal serum chemistry, hematology and baseline T, LH, and FSH levels)
- •body mass index ≥18 and ≤32 kg/m2
- •must agree not to participate in another research study involving drug exposure for the duration of the study
排除标准
- •men in poor general health, with abnormal blood results
- •sperm counts <20 million/ml on two tests
- •chronic, ongoing alcohol or drug abuse
- •participation in a long-term male contraceptive study within the past three months
- •history of testicular or scrotal surgery
- •history of infertility
- •abnormal testicular exam
- •abnormal DRE
- •chronic pain syndrome
- •use of steroids, testosterone, or medications which might interfere with androgen metabolism including ketoconazole, glucocorticoids
- •known bleeding disorder
- •use of medications which may affect bleeding time (ongoing aspirin or anti-inflammatory use, coumadin)
结局指标
主要结局
Intratesticular Hormones in Normal Men
时间窗: 6-weeks
Average between right and left testis for each subject and serum hormone concentration in 10 normal men
次要结局
未报告次要终点
研究者
John Amory
Professor
University of Washington