Pharmacokinetics of Testosterone Lotion in the Treatment of Hypogonadal Males

This study has been completed.

First Received: September 5, 2006 Last Updated: June 18, 2008 History of Changes

Sponsor:	Acrux DDS Pty Ltd
Information provided by:	Acrux DDS Pty Ltd
ClinicalTrials.gov Identifier:	NCT00372008

Purpose

Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a proprietry testosterone replacement product - Testosterone-MD Lotion, and this study will evaluate the efficacy and safety of this product.

Condition	Intervention	Phase
Hypogonadism	Drug: Testosterone	Phase II

Study Type:	Interventional
Study Design:	Randomized, Open Label, Uncontrolled, Crossover Assignment
Official Title:	A Phase II Randomised, Two-Way Crossover Study to Compare the Steady State Pharmacokinetics of Testosterone Following Application of Different Testosterone Metered-Dose (MD) Lotion Doses in Hypogonadal Male Subjects

Resource links provided by NLM:

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Further study details as provided by Acrux DDS Pty Ltd:

Primary Outcome Measures:

Pharmacokinetic

Secondary Outcome Measures:

Safety and tolerability

Estimated Enrollment:	40
Study Start Date:	October 2006
Study Completion Date:	April 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Hypogonadal males between 18-70 years old with qualifying general medical health

Exclusion Criteria:

Disqualifying concurrent conditions or allergy/sensitivity to testosterone replacement therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372008

Locations

United States, Alabama
Birmingham
Birmingham, Alabama, United States
United States, California

Torrance, California, United States

La Mesa, California, United States
United States, Connecticut

New Britain, Connecticut, United States
United States, Florida

Ocala, Florida, United States
United States, Louisiana

Shreveport, Louisiana, United States
United States, Texas

San Antonio, Texas, United States

Sponsors and Collaborators

Acrux DDS Pty Ltd

Investigators

Study Director:

Tina Soulis, PhD

Acrux Ltd

More Information

No publications provided

Study ID Numbers:	MTE05
Study First Received:	September 5, 2006
Last Updated:	June 18, 2008
ClinicalTrials.gov Identifier:	NCT00372008 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Methyltestosterone
Hormones

Pharmacologic Actions
Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Hypogonadism
Therapeutic Uses
Androgens

ClinicalTrials.gov processed this record on February 08, 2010