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)

Acrux DDS Pty Ltd1 site in 1 country36 target enrollmentJanuary 2009

ConditionsHypogonadism

InterventionsTestosterone MD-Lotion

DrugsTestosterone MD-Lotion

Overview

Phase: Phase 1
Intervention: Testosterone MD-Lotion
Conditions: Hypogonadism
Sponsor: Acrux DDS Pty Ltd
Enrollment: 36
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

April 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Acrux DDS Pty Ltd

Eligibility Criteria

Inclusion Criteria

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