Phase 2
N=57
Efficacy and Tolerability of an Intra-Nasal Testosterone Product
Hypogonadism
Bottom Line
View on ClinicalTrials.gov: NCT00975650 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Serum Testosterone Ln-Cmax — 6.25; 6.41; 6.54; 6.36 ng/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nasobol® (Drug); Androderm® (Positive Control) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Acerus Pharmaceuticals Corporation
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Testosterone Ln-Cmax |
6.25; 6.41; 6.54; 6.36 | — |
| PRIMARY Serum Testosterone Ln-AUCt |
8.80; 8.90; 8.95; 9.09 | — |
| PRIMARY Serum Testosterone Cavg |
287.10; 316.64; 336.11; 384.62 | — |
| PRIMARY Serum Dihydrotestosterone Ln-Cmax |
3.54; 3.67; 3.80; 3.44 | — |
| PRIMARY Serum Dihydrotestosterone Ln-AUCt |
6.34; 6.47; 6.52; 6.33 | — |
| PRIMARY Serum Dihydrotestosterone Cavg |
25.24; 28.97; 30.79; 24.69 | — |
| PRIMARY Percentage of Subjects With Cavg Within the Reference Range |
19; 27; 27; 42; 24; 31 | — |
Summary
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.
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 (NCT00975650). 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.