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

This study has been completed.
Sponsor:
Information provided by:
Acrux DDS Pty Ltd
ClinicalTrials.gov Identifier:
NCT00857168
First received: March 5, 2009
Last updated: October 12, 2009
Last verified: October 2009
History of Changes
  Purpose

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 Intervention Phase
Hypogonadism
 Drug: Testosterone MD-Lotion
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Acrux DDS Pty Ltd:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety and tolerability of Testosterone MD-Lotion® (cutaneous solution) following single dose application. [ Time Frame: April 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: January 2009
Study Completion Date: April 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Tina Soulis, Director, CLinical Devleopment, Acrux Pharma Pty Ltd
ClinicalTrials.gov Identifier: NCT00857168     History of Changes
Other Study ID Numbers: MTE10
Study First Received: March 5, 2009
Last Updated: October 12, 2009
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

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

ClinicalTrials.gov processed this record on May 19, 2013