Pharmacokinetic Evaluation of Serum Testosterone Concentrations After Administration of Clomiphene Citrate

20-10022773

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).

2022-05-01

2025-01-01

2025-01-01

Recruiting

Early phase I

40

Inclusion Criteria: * 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 Exclusion Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Individuals will be divided into two groups. Group 1 will receive clomiphene citrate at a dose of 25mg daily and will take one-half of a 50mg tablet daily. Group 2 will receive clomiphene citrate at a dose of 50mg every other day and will take one 50mg tablet every other day.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open Label'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2023-12-20