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Pharmacokinetics of Testosterone Lotion in the Treatment of Hypogonadal Males

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. Identifier: NCT00372008
Recruitment Status : Completed
First Posted : September 6, 2006
Last Update Posted : June 20, 2008
Information provided by:
Acrux DDS Pty Ltd

Brief Summary:
Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a proprietry testosterone replacement product - Testosterone-MD Lotion, and this study will evaluate the efficacy and safety of this product.

Condition or disease Intervention/treatment Phase
Hypogonadism Drug: Testosterone Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Phase II Randomised, Two-Way Crossover Study to Compare the Steady State Pharmacokinetics of Testosterone Following Application of Different Testosterone Metered-Dose (MD) Lotion Doses in Hypogonadal Male Subjects
Study Start Date : October 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Pharmacokinetic

Secondary Outcome Measures :
  1. Safety and tolerability

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Hypogonadal males between 18-70 years old with qualifying general medical health

Exclusion Criteria:

  • Disqualifying concurrent conditions or allergy/sensitivity to testosterone replacement therapy

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 identifier (NCT number): NCT00372008

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United States, Alabama
Birmingham, Alabama, United States
United States, California
La Mesa, California, United States
Torrance, California, United States
United States, Connecticut
New Britain, Connecticut, United States
United States, Florida
Ocala, Florida, United States
United States, Louisiana
Shreveport, Louisiana, United States
United States, Texas
San Antonio, Texas, United States
Sponsors and Collaborators
Acrux DDS Pty Ltd
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Study Director: Tina Soulis, PhD Acrux Ltd

Layout table for additonal information Identifier: NCT00372008     History of Changes
Other Study ID Numbers: MTE05
First Posted: September 6, 2006    Key Record Dates
Last Update Posted: June 20, 2008
Last Verified: June 2008
Additional relevant MeSH terms:
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Gonadal Disorders
Endocrine System Diseases
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents