Status:
COMPLETED
Efficacy of an Intranasal Testosterone Product
Lead Sponsor:
Acerus Pharmaceuticals Corporation
Conditions:
Hypogonadism
Eligibility:
MALE
18-80 years
Phase:
PHASE2
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01252745
Start Date
August 1 2010
End Date
December 1 2010
Last Update
May 23 2018
Active Locations (3)
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1
Quality of Life Medical and Research Center
Tucson, Arizona, United States
2
Pharmax Research Clinic Inc.
Miami, Florida, United States
3
Regional Urology LLC
Shreveport, Louisiana, United States