The Effects of Intranasal Testosterone (NatestoTM) for Treatment of Hypogonadism on Maintenance of Spermatogenesis
This is a prospective, non-blinded study of hypogonadal men with a history of testosterone therapy who became azoospermic or severely oligospermic and wish to avoid symptoms of hypogonadism during their recovery of spermatogenesis in an effort to establish paternity. The study will determine if Natesto can alleviate hypogonadal symptoms while preserving the recovery of spermatogenesis
• Male between 18 and 64 years of age, with documented onset of testosterone induced hypogonadism with impaired semen parameters who are attempting to achieve a successful pregnancy.
• Documented diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired).
• Serum total testosterone \< 350 ng/dL based on 2 consecutive blood samples obtained 1-4 weeks apart between 6 and 10 AM following an appropriate washout of current androgen replacement therapy; with clinical symptoms of hypogonadism such as diminished energy and sexual function; and/or a decreased sperm count (\<20 million sperm/mL semen).
• Discontinued current testosterone replacement treatment and completed a washout of 4 weeks following androgen treatment (excluding Testopel TM). Washout must be completed prior to collection of baseline serum testosterone samples to determine study eligibility.
• Judged to be in good general health as determined by the principal investigator based upon the results of a medical history, physical examination, vital signs, and laboratory profile.