Testosterone Deficiency
Conditions
Brief summary
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
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.
Interventions
clomiphene citrate at a dose of 25mg daily
clomiphene citrate at a dose of 50mg every other day
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
Open Label
Intervention 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.
Eligibility
Sex/Gender
MALE
Age
21 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum testosterone | Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16. | Change in serum testosterone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in FSH levels | Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16. | Serum levels of follicle-stimulating hormone (FSH) |
| Change in LH levels | Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16. | Serum levels of luteinizing hormone (LH) |
| Change in estradiol levels | Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16. | Serum levels of estradiol levels |
Countries
United States
Outcome results
None listed