Efficacy and Tolerability of an Intra-Nasal Testosterone Product
| Status: | Completed |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 8/15/2018 |
| Start Date: | August 2009 |
| End Date: | May 2010 |
Efficacy and Tolerability of Nasobol®, an Intra-Nasal Testosterone Product, for Testosterone Replacement in Hypogonadal Men
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.
after repeated intra-nasal administration of products of different strengths in subjects with
hypogonadism.
Primary Objective:
The primary objective of this study was to determine the efficacy of Nasobol in the treatment
of hypogonadal men requiring testosterone replacement therapy. Efficacy was determined by
establishing a pharmacokinetic profile for serum testosterone levels following Nasobol
treatment, and comparing it to that of the active control, Androderm®.
Secondary Objective:
To establish a safety profile for Nasobol.
The primary objective of this study was to determine the efficacy of Nasobol in the treatment
of hypogonadal men requiring testosterone replacement therapy. Efficacy was determined by
establishing a pharmacokinetic profile for serum testosterone levels following Nasobol
treatment, and comparing it to that of the active control, Androderm®.
Secondary Objective:
To establish a safety profile for Nasobol.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
We found this trial at
6
sites
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