NCT00996151

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

March 2, 2010

Status Verified

February 1, 2010

Enrollment Period

2 months

First QC Date

October 12, 2009

Last Update Submit

February 28, 2010

Conditions

Hypergonadism

Keywords

HypergonadismTestosterone Transfer

Outcome Measures

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.

    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).

    March 2010

Interventions

Testosterone MD-LotionDRUG

Single dose Testosterone MD-Lotion 2%

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male subjects ≥18 and ≤ 70 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QPharm Pty Ltd

Brisbane, Queensland, 4006, Australia

Location

Study Officials

  • Tina Soulis, PhD

    Acrux Pharma Pty Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 12, 2009

First Posted

October 16, 2009

Study Start

December 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

March 2, 2010

Record last verified: 2010-02

Locations

AU(1)