Testosterone Deficiency Clinical Trial
Official title:
Pharmacokinetic Evaluation of Serum Testosterone Concentrations After Administration of Clomiphene Citrate
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).
Status | Recruiting |
Enrollment | 40 |
Est. completion date | January 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 21 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Weill Cornell Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University |
United States,
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Murdter TE, Kerb R, Turpeinen M, Schroth W, Ganchev B, Bohmer GM, Igel S, Schaeffeler E, Zanger U, Brauch H, Schwab M. Genetic polymorphism of cytochrome P450 2D6 determines oestrogen receptor activity of the major infertility drug clomiphene via its active metabolites. Hum Mol Genet. 2012 Mar 1;21(5):1145-54. doi: 10.1093/hmg/ddr543. Epub 2011 Nov 22. — View Citation
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in serum testosterone | Change in serum testosterone | Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16. | |
Secondary | Change in FSH levels | Serum levels of follicle-stimulating hormone (FSH) | Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16. | |
Secondary | Change in LH levels | Serum levels of luteinizing hormone (LH) | Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16. | |
Secondary | Change in estradiol levels | Serum levels of estradiol levels | Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16. |
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