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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

NCT ID: NCT01133548

Last Updated: 2017-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-07-31

Brief Summary

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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

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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.

Conditions

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Hypogonadism

Keywords

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testosterone, hypogonadal, males

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Testosterone Gel 1.62%

Group Type EXPERIMENTAL

Testosterone Gel 1.62%

Intervention Type DRUG

5 grams administered using an application Site Rotation

Testosterone Gel 1.62%

Intervention Type DRUG

5 grams administered using an a combination of Application sites

Interventions

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Testosterone Gel 1.62%

5 grams administered using an application Site Rotation

Intervention Type DRUG

Testosterone Gel 1.62%

5 grams administered using an a combination of Application sites

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael miller, PharmD

Role: STUDY_DIRECTOR

Abbott

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 21492400 (View on PubMed)

Other Identifiers

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S176.1.010

Identifier Type: -

Identifier Source: org_study_id