Efficacy of an Intranasal Testosterone Product

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01252745
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : December 3, 2010
Information provided by:
Acerus Pharmaceuticals Corporation

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

Condition or disease Intervention/treatment Phase
Hypogonadism Drug: Testosterone Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Randomized, Balanced, Three Treatment, Parallel Design, Pharmacokinetic Study of Intranasal TBS-1 Administration to Hypogonadal Men
Study Start Date : August 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 5.0 mg Testosterone t.i.d. Drug: Testosterone
Experimental: 6.75 mg Testosterone b.i.d. Drug: Testosterone
Experimental: 5.625 mg Testosterone t.i.d. Drug: Testosterone

Primary Outcome Measures :
  1. Pharmacokinetic profile of serum testosterone [ Time Frame: 7 days ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01252745

United States, Arizona
Quality of Life Medical and Research Center
Tuscon, Arizona, United States
United States, Florida
Pharmax Research Clinic Inc.
Miami, Florida, United States
United States, Louisiana
Regional Urology LLC
Sherveport, Louisiana, United States
Sponsors and Collaborators
Acerus Pharmaceuticals Corporation

Responsible Party: Len Rosenberg, Trimel BioPharma Identifier: NCT01252745     History of Changes
Other Study ID Numbers: TBS-1-2010-01
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: December 3, 2010
Last Verified: December 2010

Additional relevant MeSH terms:
Gonadal Disorders
Endocrine System Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents