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To Determine the Effects of Deodorant, Antiperspirant and Washing on the Pharmacokinetics of 2% Testosterone MD Lotion (MTE10)

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.
ClinicalTrials.gov Identifier: NCT00857168
Recruitment Status : Completed
First Posted : March 6, 2009
Last Update Posted : October 14, 2009
Sponsor:
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 propriety testosterone replacement product, Testosterone MD-Lotion and this study will evaluate the impact of application of antiperspirant and deodorant on absorption of testosterone, when applied pre-application of Testosterone MD-Lotion® (cutaneous solution).

The study also aim to evaluate the impact of washing the application site on the absorption of testosterone, when washed post-application of Testosterone MD-Lotion® (cutaneous solution).


Condition or disease Intervention/treatment Phase
Hypogonadism Drug: Testosterone MD-Lotion Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Phase I Trial to Determine the Impact of Application of Antiperspirant and Deodorant as Well as Washing the Application Site, on the Pharmacokinetics of Testosterone Following Single Dose Applications of 2% Testosterone MD-Lotion® (Cutaneous Solution)
Study Start Date : January 2009
Primary Completion Date : February 2009
Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Group 1 Drug: Testosterone MD-Lotion
Active Comparator: Group 2 Drug: Testosterone MD-Lotion
Active Comparator: Group 3 Drug: Testosterone MD-Lotion
Active Comparator: Group 4 Drug: Testosterone MD-Lotion
Active Comparator: Group 5 Drug: Testosterone MD-Lotion
Active Comparator: Group 6 Drug: Testosterone MD-Lotion



Primary Outcome Measures :
  1. To evaluate the impact of application of antiperspirant and deodorant on absorption of testosterone, when applied pre-application of Testosterone MD-Lotion® (cutaneous solution). Also to evaluate the impact of washing. [ Time Frame: April 2009 ]

Secondary Outcome Measures :
  1. To assess the safety and tolerability of Testosterone MD-Lotion® (cutaneous solution) following single dose application. [ Time Frame: April 2009 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy premenopausal female subjects ≥18 and ≤45 years of age with qualifying general medical health.

Exclusion Criteria:

  • Disqualifying concurrent condition 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 ClinicalTrials.gov identifier (NCT number): NCT00857168


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

Responsible Party: Tina Soulis, Director, CLinical Devleopment, Acrux Pharma Pty Ltd
ClinicalTrials.gov Identifier: NCT00857168     History of Changes
Other Study ID Numbers: MTE10
First Posted: March 6, 2009    Key Record Dates
Last Update Posted: October 14, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
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