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

Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01133548
• Other study ID #: S176.1.010
• Status: Completed
• Phase: Phase 1
• First received: May 21, 2010
• Last updated: December 5, 2017
• Start date: May 2010
• Est. completion date: July 2010

Study information

• Verified date: June 2011
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• Testosterone Gel 1.62%
5 grams administered using an application Site Rotation
• Testosterone Gel 1.62%
5 grams administered using an a combination of Application sites

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration observed (Cmax)	Maximum plasma concentration observed (Cmax) of total testosterone, dihydrotestosterone, estradiol	Up to 24 days
Primary	Area Under the Plasma Concentration-time Curve (AUC)	Area under the plasma concentration-time curve (AUC) of total testosterone, dihydrotestosterone, estradiol	Up to 24 days
Primary	Time of Cmax (Tmax)	Time of Cmax (Tmax) of total testosterone, dihydrotestosterone, estradiol	Up to 24 days
Primary	Average Plasma Concentration observed (Cav)	Average plasma concentration observed (Cav) of total testosterone, dihydrotestosterone, estradiol	Up to 24 days
Secondary	Application site evaluation based on the clinical evaluation of skin reactions grading scale		24 days
Secondary	Adverse events		24 days