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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
clomiphene citrate at a dose of 25mg daily
clomiphene citrate at a dose of 50mg every other day
Weill Cornell Medicine
New York, New York, United States
Change in serum testosterone
Change in serum testosterone
Time frame: Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16.
Change in FSH levels
Serum levels of follicle-stimulating hormone (FSH)
Time frame: 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)
Time frame: 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
Time frame: Evaluation will occur at baseline, day 2, day 4, weeks 1 - 4, and again at weeks 8, 12, and 16.
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