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Completed

NCT Number: NCT01252745

Efficacy of an Intranasal Testosterone Product

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

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Key information

Conditions

Hypogonadism Endocrine System Diseases Gonadal Disorders

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Quality of Life Medical and Research Center, Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

10.0 mg of Testosterone, 4.0% TID

Drug

Other names: 10.0 mg of TBS-1, 4.0% TID

13.5 mg of Testosterone, 4.5% B.I.D

Drug

Other names: 13.5 mg of TBS-1, 4.5% B.I.D

11.25 mg of Testosterone, 4.5% T.I.D

Drug

Other names: 11.25 mg of TBS-1, 4.5% T.I.D

Primary outcomes

  1. Cmax of Serum Testosterone

    Time frame: 24 hours

  2. Cavg of Serum Testosterone

    Time frame: 24 hours

  3. AUC0-t of Serum Testosterone

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Acerus Pharmaceuticals Corporation

Industry

Registry information

Official study title

An Open Label, Randomized, Balanced, Three Treatment, Parallel Design, Pharmacokinetic Study of Intranasal TBS-1 Administration to Hypogonadal Men

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 3, 2010
Registry last updated
May 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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