Efficacy of an Intranasal Testosterone Product
| Status: | Completed |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 5/25/2018 |
| Start Date: | August 2010 |
| End Date: | December 2010 |
An Open Label, Randomized, Balanced, Three Treatment, Parallel Design, Pharmacokinetic Study of Intranasal TBS-1 Administration to Hypogonadal Men
This clinical trial will compare the pharmacokinetic profile of testosterone after repeated
intranasal administration of TBS-1 of different strengths in subjects with hypogonadism
intranasal administration of TBS-1 of different strengths in subjects with hypogonadism
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.
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