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Completed

NCT Number: NCT00996151

Testosterone MD-Lotion Residual Washing Study

The study will evaluate the amount of Testosteron MD-Lotion 2% remaining on the axilla after a single dose application in healthy males who undergo a post dose washing procedure.

Completed

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Key information

Conditions

Hypergonadism

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

QPharm Pty Ltd

Brisbane, Queensland, 4006, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male subjects ≥18 and ≤ 70 years

Exclusion criteria

  • Disqualifying concurrent condition or allergy/sensitivity to Testosterone MD-Lotion

Treatment and study plan

Testosterone MD-Lotion

Drug

Single dose Testosterone MD-Lotion 2%

Primary outcomes

  1. The amount of Testerone MD-Lotion 2% remaining on the axilla after a single dose application in healthy males who undergo a post dose washing procedure.

    Time frame: March 2010

Secondary outcomes

  1. The safety and tolerability of Testosterone MD-Lotion 2% following a single dose application. This will be performed by review of adverse events, EKG and assessment of laboratory parameters (haematology, biochemistry, urinalysis and hormone levels).

    Time frame: March 2010

Sponsors and collaborators

Lead sponsor

Acrux DDS Pty Ltd

Industry

Registry information

Official study title

A Healthy Volunteer, Single Dose Phase I Trial to Determine the Amount of Testerone MD-Lotion 2% Remaining on the Axilla After Washing.

Acronym: MTE11

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 16, 2009
Registry last updated
Mar 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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