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OpenTrials
Completed

NCT Number: NCT00857168

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

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).

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Key information

Conditions

Hypogonadism Endocrine System Diseases Gonadal Disorders

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

QPharm Pty Ltd

Brisbane, Queensland, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Testosterone MD-Lotion

Drug

Primary outcomes

  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 outcomes

  1. To assess the safety and tolerability of Testosterone MD-Lotion® (cutaneous solution) following single dose application.

    Time frame: April 2009

Sponsors and collaborators

Lead sponsor

Acrux DDS Pty Ltd

Industry

Registry information

Official study 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)

Acronym: MTE10

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 6, 2009
Registry last updated
Oct 14, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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