Pharmacokinetic Evaluation of Serum Testosterone Concentrations After Administration of Clomiphene Citrate
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in serum testosterone
研究概览
简要总结
This is a randomized, open-label trial examining two doses of clomiphene citrate in men with low serum testosterone concentrations (total testosterone (TT) < 300 ng/dl).
详细描述
This is a randomized, open-label trial examining two doses of clomiphene citrate in men with low serum testosterone concentrations (total testosterone (TT) < 300 ng/dl). The investigators will perform a pharmacokinetic analysis of serum hormone concentrations (TT, LH, FSH, estradiol) after medication administration. Researchers hypothesize that testosterone levels will increase in both groups and this may allow to dose clomiphene citrate so that patients do not need to take the medication daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, 21-45 years of age
- •Serum testosterone concentration < 300 ng/dl measured on two separate occasions (separated by at least one week), with collection prior to 10AM
排除标准
- •Serum testosterone concentration > 300 ng/dl
- •Abnormal serum prolactin (PRL) concentration (PRL > 15.2 ng/ml)
- •Concurrent or prior use of hormone-modifying medications (clomiphene citrate or other SERM, testosterone replacement therapy or other testosterone-containing products/treatments, gonadotropin therapy, aromatase inhibitors, estrogen-containing products/treatments)
- •Documented karyotype abnormality
- •Diagnosis of Kallmann syndrome
- •Any prior chemotherapy, radiation therapy to the groin/pelvis, or known exposure to gonadotoxic agents
- •History of cryptorchidism or prior orchiopexy
- •History of testicular cancer or prior orchiectomy
- •History of pituitary tumor or resection of pituitary tumor
- •History of prostate cancer or severe benign prostatic hypertrophy
- •History of epididymitis or epididymo-orchitis, or orchitis (including mumps)
- •History of primary hypogonadism
- •History of prior urinary tract infection
- •History of intravenous drug use
- •Any of the following comorbidities: renal insufficiency, heart disease, peptic ulcer disease, cerebrovascular disease, liver disease, psychiatric disorders, chronic pain, bleeding diatheses, anemia, polycythemia, vision problems
- •Medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this trial, or constitutes an unacceptable risk to the subject
- •Documented allergy or hypersensitivity to clomiphene citrate or other SERM
研究组 & 干预措施
Clomiphene citrate 25 mg daily for 12 weeks
干预措施: Clomiphene Citrate 25mg (Drug)
Clomiphene citrate 50 mg every other day for 12 weeks
干预措施: Clomiphene Citrate 50mg (Drug)
结局指标
主要结局
Change in serum testosterone
时间窗: Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16.
Change in serum testosterone
次要结局
- Change in FSH levels(Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16.)
- Change in LH levels(Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16.)
- Change in estradiol levels(Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16.)