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An Open-Label Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure to Testosterone Gel 1.62% Applied to the Upper Arms and Shoulders and Use of a T-shirt Barrier

NCT ID: NCT01130298

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-05-31

Brief Summary

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Single-center, single dose, open-label study in healthy male and female volunteers to further characterize the transfer potential of Testosterone Gel 1.62% formulation.

Detailed Description

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Single-center, single dose, open-label study in 12 healthy male and 12 healthy female volunteers to further characterize the transfer potential of Testosterone Gel 1.62% formulation.

Conditions

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Healthy

Keywords

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testosterone, Pharmacokinetics replacement, therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Testosterone Gel 1.62%

Intervention Type DRUG

5 grams

Interventions

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Testosterone Gel 1.62%

5 grams

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* BMI between 20-35 kg/m\^2 inclusive.

Exclusion Criteria

* Males: history, current or suspected prostate or breast cancer.
* Females: pregnant or lactating.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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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Stahlman J, Britto M, Fitzpatrick S, McWhirter C, Testino SA, Brennan JJ, Zumbrunnen TL. Serum testosterone levels in non-dosed females after secondary exposure to 1.62% testosterone gel: effects of clothing barrier on testosterone absorption. Curr Med Res Opin. 2012 Feb;28(2):291-301. doi: 10.1185/03007995.2011.652732. Epub 2012 Jan 24.

Reference Type RESULT
PMID: 22188558 (View on PubMed)

Other Identifiers

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S176.1.011

Identifier Type: -

Identifier Source: org_study_id