We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Testosterone MD-Lotion Residual Washing Study (MTE11)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00996151
First Posted: October 16, 2009
Last Update Posted: March 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Acrux DDS Pty Ltd
  Purpose
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.

Condition Intervention Phase
Hypergonadism Drug: Testosterone MD-Lotion Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Healthy Volunteer, Single Dose Phase I Trial to Determine the Amount of Testerone MD-Lotion 2% Remaining on the Axilla After Washing.

Resource links provided by NLM:


Further study details as provided by Acrux DDS Pty Ltd:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: December 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Testosterone MD-Lotion
    Single dose Testosterone MD-Lotion 2%
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subjects ≥18 and ≤ 70 years

Exclusion Criteria:

  • Disqualifying concurrent condition or allergy/sensitivity to Testosterone MD-Lotion
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00996151


Locations
Australia, Queensland
QPharm Pty Ltd
Brisbane, Queensland, Australia, 4006
Sponsors and Collaborators
Acrux DDS Pty Ltd
Investigators
Study Director: Tina Soulis, PhD Acrux Pharma Pty Ltd
  More Information

Responsible Party: Tina Soulis, Director, Clinical Development, Acrux Pharma Pty Ltd
ClinicalTrials.gov Identifier: NCT00996151     History of Changes
Other Study ID Numbers: MTE11
First Submitted: October 12, 2009
First Posted: October 16, 2009
Last Update Posted: March 2, 2010
Last Verified: February 2010

Keywords provided by Acrux DDS Pty Ltd:
Hypergonadism
Testosterone Transfer

Additional relevant MeSH terms:
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents


To Top