Testosterone MD-Lotion Residual Washing Study

Phase 1

Completed

• Conditions: Hypergonadism

• Registration Number: NCT00996151
• Lead Sponsor: Acrux DDS Pty Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-12
• Study First Submitted QC: 2009-10-15
• Study First Posted: 2009-10-16
• Study Start: 2009-12
• Status Verified: 2010-02
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Last Update Submitted: 2010-02-28
• Last Update Posted: 2010-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

• Healthy male subjects ≥18 and ≤ 70 years

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	March 2010

Secondary Outcome Measures

Name	Time	Method
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).	March 2010

Trial Locations

Locations (1)

QPharm Pty Ltd; 🇦🇺 Brisbane, Queensland, Australia