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

December 5, 2017 updated by: AbbVie

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Testosterone Gel 1.62%
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Plasma Concentration observed (Cmax)
Time Frame: Up to 24 days
Maximum plasma concentration observed (Cmax) of total testosterone, dihydrotestosterone, estradiol
Up to 24 days
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
Up to 24 days
Time of Cmax (Tmax)
Time Frame: Up to 24 days
Time of Cmax (Tmax) of total testosterone, dihydrotestosterone, estradiol
Up to 24 days
Average Plasma Concentration observed (Cav)
Time Frame: Up to 24 days
Average plasma concentration observed (Cav) of total testosterone, dihydrotestosterone, estradiol
Up to 24 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Application site evaluation based on the clinical evaluation of skin reactions grading scale
Time Frame: 24 days
24 days
Adverse events
Time Frame: 24 days
24 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

May 21, 2010

First Submitted That Met QC Criteria

May 28, 2010

First Posted (Estimate)

May 31, 2010

Study Record Updates

Last Update Posted (Actual)

December 7, 2017

Last Update Submitted That Met QC Criteria

December 5, 2017

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S176.1.010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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