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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01133548

Enrollment

Registered

2010-05-31

Start date

2010-05-31

Completion date

2010-07-31

Last updated

2017-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadism

Keywords

testosterone, hypogonadal, males

Brief 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.

Detailed description

Interventions

DRUGTestosterone Gel 1.62%

5 grams administered using an application Site Rotation

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Maximum Plasma Concentration observed (Cmax)	Up to 24 days	Maximum plasma concentration observed (Cmax) of total testosterone, dihydrotestosterone, estradiol
Area Under the Plasma Concentration-time Curve (AUC)	Up to 24 days	Area under the plasma concentration-time curve (AUC) of total testosterone, dihydrotestosterone, estradiol
Time of Cmax (Tmax)	Up to 24 days	Time of Cmax (Tmax) of total testosterone, dihydrotestosterone, estradiol
Average Plasma Concentration observed (Cav)	Up to 24 days	Average plasma concentration observed (Cav) of total testosterone, dihydrotestosterone, estradiol

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026