Phase 2
Completed N=22
Efficacy of an Intranasal Testosterone Product
Source: ClinicalTrials.gov NCT01252745 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcomePrimary: Cmax of Serum Testosterone — 830; 1050; 883 ng/dL
Summary
This clinical trial will compare the pharmacokinetic profile of testosterone after repeated intranasal administration of TBS-1 of different strengths in subjects with hypogonadism
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax of Serum Testosterone |
830; 1050; 883 | — |
| PRIMARY Cavg of Serum Testosterone |
413; 408; 396 | — |
| PRIMARY AUC0-t of Serum Testosterone |
9920.07; 9781.39; 9505.03 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01252745). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.