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Pharmacokinetic and Comparative Bioavailability Study of Testosterone Absorption After Administration of Testosterone Gel 1.62% to the Upper Arms/Shoulders Using an Application Site Rotation or a Combination of Application Sites in Hypogonadal Males

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01133548
First received: May 21, 2010
Last updated: June 30, 2011
Last verified: June 2011
History of Changes

May 21, 2010
June 30, 2011
May 2010
July 2010   (final data collection date for primary outcome measure)
Pharmacokinetic Parameters Total Testosterone, dihydrotestosterone, estradiol AUC, Cav, Cmax, Tmax [ Time Frame: 24 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01133548 on ClinicalTrials.gov Archive Site
  • Application site evaluation based on the clinical evaluation of skin reactions grading scale [ Time Frame: 24 days ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: 24 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetic and Comparative Bioavailability Study of Testosterone Absorption After Administration of Testosterone Gel 1.62% to the Upper Arms/Shoulders Using an Application Site Rotation or a Combination of Application Sites in Hypogonadal Males
A Multiple Dose Pharmacokinetic and Comparative Bioavailability Study of Testosterone Absorption After Administration of 5 g Testosterone Gel 1.62% to the Upper Arms/Shoulders Using an Application Site Rotation or a Combination of Application Sites in Hypogonadal Males

To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites.

To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypogonadism
  • Drug: Testosterone Gel 1.62%
    5 grams administered using an application Site Rotation
  • Drug: Testosterone Gel 1.62%
    5 grams administered using an a combination of Application sites
Experimental: 1
Testosterone Gel 1.62%
Interventions:
  • Drug: Testosterone Gel 1.62%
  • Drug: Testosterone Gel 1.62%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria

  1. Hypogonadal males
  2. Screening testosterone <300 ng/dL

Exclusion Criteria

  1. Smokers
  2. Previous history of or current or suspected prostate or breast cancer
Male
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01133548
S176.1.010
No
Michael Miller, Project Director, Abbott
Abbott
Not Provided
Study Director: Michael miller, PharmD Abbott
Abbott
June 2011

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