Pharmacokinetic Evaluation of Serum Testosterone Concentrations After Administration of Clomiphene Citrate

Who can take part

• 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

Who cannot take part

• 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)
• 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 prior urinary tract infection
• 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
• Diagnosis of Kallmann syndrome
• 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 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
• Documented allergy or hypersensitivity to clomiphene citrate or other SERM
• Serum testosterone concentration > 300 ng/dl
• Abnormal serum prolactin (PRL) concentration (PRL > 15.2 ng/ml)
• Documented karyotype abnormality