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Efficacy of an Intranasal Testosterone Product

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ClinicalTrials.gov Identifier: NCT01252745
Recruitment Status : Completed
First Posted : December 3, 2010
Results First Posted : April 26, 2018
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Acerus Pharmaceuticals Corporation

December 1, 2010
December 3, 2010
February 15, 2018
April 26, 2018
April 26, 2018
August 2010
November 2010   (Final data collection date for primary outcome measure)
  • Cmax of Serum Testosterone [ Time Frame: 24 hours ]
    To determine the systemic bioavailability (24 hour AUC, Cavg, Cmax) of a 4.0% TBS-1 gel (applied t.i.d.) and 4.5% TBS-1 gel (applied b.i.d. and t.i.d.) in hypogonadal men.
  • Cavg of Serum Testosterone [ Time Frame: 24 hours ]
  • AUC0-t of Serum Testosterone [ Time Frame: 24 hours ]
Pharmacokinetic profile of serum testosterone [ Time Frame: 7 days ]
Complete list of historical versions of study NCT01252745 on ClinicalTrials.gov Archive Site
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Efficacy of an Intranasal Testosterone Product
An Open Label, Randomized, Balanced, Three Treatment, Parallel Design, Pharmacokinetic Study of Intranasal TBS-1 Administration to Hypogonadal Men
This clinical trial will compare the pharmacokinetic profile of testosterone after repeated intranasal administration of TBS-1 of different strengths in subjects with hypogonadism
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hypogonadism
  • Drug: 10.0 mg of Testosterone, 4.0% TID
    Other Name: 10.0 mg of TBS-1, 4.0% TID
  • Drug: 13.5 mg of Testosterone, 4.5% B.I.D
    Other Name: 13.5 mg of TBS-1, 4.5% B.I.D
  • Drug: 11.25 mg of Testosterone, 4.5% T.I.D
    Other Name: 11.25 mg of TBS-1, 4.5% T.I.D
  • Experimental: 10.0 mg of TBS-1, 4.0% T.I.D.
    TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day)
    Intervention: Drug: 10.0 mg of Testosterone, 4.0% TID
  • Experimental: 13.5 mg of TBS-1, 4.5% B.I.D
    TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and 0700 hours. (total dose 27.0 mg/day)
    Intervention: Drug: 13.5 mg of Testosterone, 4.5% B.I.D
  • Experimental: 11.25 mg of TBS-1, 4.5% T.I.D
    TBS-1 syringes pre-filled with 125 μL 4.5% gel to deliver 5.625 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 33.75 mg/day)
    Intervention: Drug: 11.25 mg of Testosterone, 4.5% T.I.D
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
30
December 2010
November 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01252745
TBS-1-2010-01
No
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Acerus Pharmaceuticals Corporation
Acerus Pharmaceuticals Corporation
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Not Provided
Acerus Pharmaceuticals Corporation
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP