Efficacy of an Intranasal Testosterone Product

Completed · Phase 2

Conditions studied: Hypogonadism

In brief

This clinical trial will compare the pharmacokinetic profile of testosterone after repeated intranasal administration of TBS-1 of different strengths in subjects with hypogonadism

Key facts

Study ID

NCT01252745

Run by

Acerus Pharmaceuticals Corporation

People needed

22

Starts

2010-08-01

Expected to finish

2010-12-01

Last updated by the study team

2018-05-23

Who can join

Age: 18 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Quality of Life Medical and Research Center — Tucson, Arizona, United States
• Pharmax Research Clinic Inc. — Miami, Florida, United States
• Regional Urology LLC — Shreveport, Louisiana, United States

Full record on ClinicalTrials.gov

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