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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

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ClinicalTrials.gov Identifier: NCT01133548
Recruitment Status : Completed
First Posted : May 31, 2010
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

May 21, 2010
May 31, 2010
December 7, 2017
May 2010
July 2010   (Final data collection date for primary outcome measure)
  • Maximum Plasma Concentration observed (Cmax) [ Time Frame: Up to 24 days ]
    Maximum plasma concentration observed (Cmax) of total testosterone, dihydrotestosterone, estradiol
  • Area Under the Plasma Concentration-time Curve (AUC) [ Time Frame: Up to 24 days ]
    Area under the plasma concentration-time curve (AUC) of total testosterone, dihydrotestosterone, estradiol
  • Time of Cmax (Tmax) [ Time Frame: Up to 24 days ]
    Time of Cmax (Tmax) of total testosterone, dihydrotestosterone, estradiol
  • Average Plasma Concentration observed (Cav) [ Time Frame: Up to 24 days ]
    Average plasma concentration observed (Cav) of total testosterone, dihydrotestosterone, estradiol
Pharmacokinetic Parameters Total Testosterone, dihydrotestosterone, estradiol AUC, Cav, Cmax, Tmax [ Time Frame: 24 days ]
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 ]
  • Adverse events [ Time Frame: 24 days ]
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
Intervention Model: Crossover Assignment
Masking: None (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%
Kaufman JM, Miller MG, Garwin JL, Fitzpatrick S, McWhirter C, Brennan JJ. Efficacy and safety study of 1.62% testosterone gel for the treatment of hypogonadal men. J Sex Med. 2011 Jul;8(7):2079-89. doi: 10.1111/j.1743-6109.2011.02265.x. Epub 2011 Apr 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
36
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
Sexes Eligible for Study: Male
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01133548
S176.1.010
No
Not Provided
Not Provided
AbbVie
AbbVie
Not Provided
Study Director: Michael miller, PharmD Abbott
AbbVie
June 2011

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