Testosterone MD-Lotion Residual Washing Study (MTE11)

This study has been completed.
Sponsor:
Information provided by:
Acrux DDS Pty Ltd
ClinicalTrials.gov Identifier:
NCT00996151
First received: October 12, 2009
Last updated: February 28, 2010
Last verified: February 2010
  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: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Tina Soulis, Director, Clinical Development, Acrux Pharma Pty Ltd
ClinicalTrials.gov Identifier: NCT00996151     History of Changes
Other Study ID Numbers: MTE11
Study First Received: October 12, 2009
Last Updated: February 28, 2010
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

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
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on August 26, 2014