Pharmacokinetic Evaluation of Serum Testosterone Concentrations After Administration of Clomiphene Citrate

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Pharmacokinetic Evaluation of Serum Testosterone Concentrations After Administration of Clomiphene Citrate

Conditions
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Testosterone Deficiency

Intervention / Treatment
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* Drug: Clomiphene Citrate 25mg
* Drug: Clomiphene Citrate 50mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clomiphene citrate 25 mg daily for 12 weeks<br> | Drug: Clomiphene Citrate 25mg<br>* clomiphene citrate at a dose of 25mg daily<br>|
| Experimental: Clomiphene citrate 50 mg every other day for 12 weeks<br> | Drug: Clomiphene Citrate 50mg<br>* clomiphene citrate at a dose of 50mg every other day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. |