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

Hypogonadism Clinical Trial

— MTE10  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00857168
• Other study ID #: MTE10
• Status: Completed
• Phase: Phase 1
• First received: March 5, 2009
• Last updated: October 12, 2009
• Start date: January 2009
• Est. completion date: April 2009

Study information

• Verified date: October 2009
• Source: Acrux DDS Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• Testosterone MD-Lotion

Locations

Country	Name	City	State
Australia	QPharm Pty Ltd	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Acrux DDS Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		April 2009	No
Secondary	To assess the safety and tolerability of Testosterone MD-Lotion® (cutaneous solution) following single dose application.		April 2009	No