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NCT Number: NCT01133548

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

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.

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Key information

Conditions

Hypogonadism Endocrine System Diseases Gonadal Disorders

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hypogonadal males
  • Screening testosterone <300 ng/dL

Exclusion criteria

  • Smokers
  • Previous history of or current or suspected prostate or breast cancer

Treatment and study plan

Testosterone gel 1.62%

Drug

5 grams administered using an application Site Rotation

Primary outcomes

  1. Maximum Plasma Concentration observed (Cmax)

    Time frame: Up to 24 days

    Maximum plasma concentration observed (Cmax) of total testosterone, dihydrotestosterone, estradiol

  2. 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

  3. Time of Cmax (Tmax)

    Time frame: Up to 24 days

    Time of Cmax (Tmax) of total testosterone, dihydrotestosterone, estradiol

  4. Average Plasma Concentration observed (Cav)

    Time frame: Up to 24 days

    Average plasma concentration observed (Cav) of total testosterone, dihydrotestosterone, estradiol

Secondary outcomes

  1. Application site evaluation based on the clinical evaluation of skin reactions grading scale

    Time frame: 24 days

  2. Adverse events

    Time frame: 24 days

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 31, 2010
Registry last updated
Dec 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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