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Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure

NCT ID: NCT00998933

Last Updated: 2009-11-25

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

2009-10-31

Study Completion Date

2009-10-31

Brief Summary

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To further characterize the transfer potential of marketed testosterone gel and new 1.62% formulation.

Detailed Description

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Conditions

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Hypogonadism

Keywords

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Testosterone replacement therapy

Study Design

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Allocation Method

NON_RANDOMIZED

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 applied topically to upper arms/shoulder and abdomen on Day 1

Interventions

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Testosterone gel 1.62%

5 grams applied topically to upper arms/shoulder and abdomen on Day 1

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female volunteers, with a BMI 20-35 kg/m2 (males) and 20-30 kg/m2 (females).

Exclusion Criteria

* Males: history, current or suspected prostate or breast cancer.
* Female: 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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Solvay Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Solvay Pharmaceuticals

Principal Investigators

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Global Clinical Director Solvay

Role: STUDY_DIRECTOR

Solvay Pharmaceuticals

Locations

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Site 1

Miami Gardens, Florida, United States

Site Status

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 DERIVED
PMID: 22188558 (View on PubMed)

Other Identifiers

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S176.1.009

Identifier Type: -

Identifier Source: org_study_id