To Determine the Effects of Deodorant, Antiperspirant and Washing on the Pharmacokinetics of 2% Testosterone MD Lotion

NCT ID: NCT00857168

Last Updated: 2009-10-14

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-04-30

Brief Summary

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Testosterone replacement treatment is the most effective way of treating hypogonadism in men.

Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will evaluate the impact of application of antiperspirant and deodorant on absorption of testosterone, when applied pre-application of Testosterone MD-Lotion® (cutaneous solution).

The study also aim to evaluate the impact of washing the application site on the absorption of testosterone, when washed post-application of Testosterone MD-Lotion® (cutaneous solution).

Detailed Description

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Conditions

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Hypogonadism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Group 1

Group Type ACTIVE_COMPARATOR

Testosterone MD-Lotion

Intervention Type DRUG

Group 2

Group Type ACTIVE_COMPARATOR

Testosterone MD-Lotion

Intervention Type DRUG

Group 3

Group Type ACTIVE_COMPARATOR

Testosterone MD-Lotion

Intervention Type DRUG

Group 4

Group Type ACTIVE_COMPARATOR

Testosterone MD-Lotion

Intervention Type DRUG

Group 5

Group Type ACTIVE_COMPARATOR

Testosterone MD-Lotion

Intervention Type DRUG

Group 6

Group Type ACTIVE_COMPARATOR

Testosterone MD-Lotion

Intervention Type DRUG

Interventions

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Testosterone MD-Lotion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy premenopausal female subjects ≥18 and ≤45 years of age with qualifying general medical health.

Exclusion Criteria

* Disqualifying concurrent condition or allergy/sensitivity to testosterone replacement therapy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Acrux DDS Pty Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Acrux Pharma Pty Ltd

Principal Investigators

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Tina Soulis, PhD

Role: STUDY_DIRECTOR

Acrux Pharma Pty Ltd

Locations

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QPharm Pty Ltd

Brisbane, Queensland, Australia

Site Status

Countries

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Australia

Other Identifiers

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MTE10

Identifier Type: -

Identifier Source: org_study_id

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