The purpose of this investigational drug study is to determine how much male hormone, testosterone, is needed to maintain sperm production in the testis.
This is a nine-month research study examining the effects on androgen treatment on sperm production in healthy men. There are three phase to the study, a 2-month screening phase, 4-month treatment and 3-month follow-up. In this study, the investigators aim to define a quantitative relationship between intra-testicular testosterone (IT-T) and spermatogenesis in man. Hormone levels will be measured in a small amount of testicular fluid at the beginning and end of treatment and sperm concentration will be measured.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Testosterone 1% gel 5g daily for 4 months \[all subjects\]
Acyline 300 ug/kg SQ injections every 2-weeks for 4 months \[all subjects\]
Dutasteride 2.5 mg (day 1) followed by 0.5 mg daily for 4 months
University of Washington Medical Center (Health Sciences)
Seattle, Washington, United States
Sperm concentration
Difference in sperm concentration at week 16 between 4 treatment groups
Time frame: 16 weeks
IT steroid concentration
It steroid concentration at week 16 between the 4 treatment groups
Time frame: 16 weeks
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ketoconazole 400 mg PO daily for 4 months
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