Efficacy and Tolerability of an Intra-Nasal Testosterone Product
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This clinical trial is being performed to compare the pharmacokinetic profile of testosterone after repeated intra-nasal administration of products of different strengths in subjects with hypogonadism.
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Ages Eligible for Study:
18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Men with primary or secondary hypogonadism and a serum morning (0900 h ± 30 minutes) testosterone levels >100 ng/dl and ≤ 300 ng/dL.
Normal Otolaryngological nasal endoscopy examination.
Normal prostate examination (no palpable prostatic mass), and serum PSA ≤ 4.0 ng/mL.
Current treatment with other androgens (i.e. DHEA), anabolic steroids or other sex hormones
Treatment with Estrogens, GnRH antagonists, or Growth Hormone within previous 12 months
History of nasal surgery, specifically turbinoplasty, septoplasty, rhinoplasty, or sinus surgery.
History of nasal disorders (e.g. polyposis, recurrent epistaxis ( > 1 nose bleed per month, abuse of nasal decongestants) or sleep apnea.