Testosterone Treatment for Hypogonadal Men

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00433199
First received: February 8, 2007
Last updated: November 3, 2011
Last verified: November 2011

February 8, 2007
November 3, 2011
February 2007
October 2007   (final data collection date for primary outcome measure)
Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 112 [ Time Frame: Day 112 ] [ Designated as safety issue: No ]
Cav results were required to fall within the normal range of 300-1000 ng/dL. Success in the study was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 112 Parmacokinetics (PK) results
Percentage of subjects with TT within the normal range
Complete list of historical versions of study NCT00433199 on ClinicalTrials.gov Archive Site
  • Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 14 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 14. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 14 PK results
  • Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 56 [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
    Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 56. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 56 PK results
  • Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 182 [ Time Frame: Day 182 ] [ Designated as safety issue: No ]
    Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 182. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 182 PK results.
  • Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266. [ Time Frame: Day 266 ] [ Designated as safety issue: No ]
    The success at Day 266 was defined as >=75% of subjects within the normal serum total testosterone concentration range of 300-1000 ng/dL. The Lower bounds of the 95% CI was to be not less than 65%.
  • Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 364. [ Time Frame: Day 364 ] [ Designated as safety issue: No ]
    The success at Day 364 was defined as >=75% of subjects within the normal serum total testosterone concentration range of 300-1000 ng/dL. The Lower bounds of the 95% CI was to be not less than 65%.
Evaluate safety for up to one year of use, TNF-alpha, IL-6, IL-10, hs-CRP, MMP-9, HDL2, HDL3, VCAM, D-Dimer, Fibrinogen, Bone-specific alkaline phosphatase, Type 1 cross-linked C telopeptide, SF-36 and % free PSA
Not Provided
Not Provided
 
Testosterone Treatment for Hypogonadal Men
A Multi-Center, Randomized, Double-Blind,Placebo-Controlled Efficacy and Safety Study of Testosterone Gel 1.62% for the Treatment of Hypogonadal Men

Demonstrate efficacy and safety of Testosterone Gel 1.62% for the treatment of hypogonadal men

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypogonadism
  • Drug: Testosterone (T) Gel 1.62%
    Testosterone gel 1.62% contains 1.62% testosterone gel as active ingredient.
  • Drug: Placebo
    Placebo Control
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Experimental: T-Gel 1.62%
    Testosterone (T) gel 1.62%
    Intervention: Drug: Testosterone (T) Gel 1.62%
Kaufman JM, Miller MG, Fitzpatrick S, McWhirter C, Brennan JJ. One-year efficacy and safety study of a 1.62% testosterone gel in hypogonadal men: results of a 182-day open-label extension of a 6-month double-blind study. J Sex Med. 2012 Apr;9(4):1149-61. doi: 10.1111/j.1743-6109.2011.02630.x. Epub 2012 Feb 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
274
April 2008
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Low T males 18 - 80 years of age

Exclusion Criteria:

  • Normal T levels
  • Elevated Prostatic Specific Antigen (PSA)
Male
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00433199
S176.3.104
Not Provided
Michael Miller, Pharm. D Project Director, Abbott
Abbott Products
Not Provided
Study Director: Global Clinical Director Solvay Abbott Products
Solvay Pharmaceuticals
November 2011

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