Titration Trial to Determine the Effectiveness of Testosterone MD-Lotion (Cutaneous Solution) Formulations

This study is not yet open for participant recruitment.

Verified by Acrux DDS Pty Ltd, June 2008

Sponsored by:	Acrux DDS Pty Ltd
Information provided by:	Acrux DDS Pty Ltd
ClinicalTrials.gov Identifier:	NCT00702650

Purpose

Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product- Testosterone MD-Lotion (cutaneous solution), and this study will evaluate the efficacy via pharmacokinetics of various doses of this product. The study will also assess safety of the product.

Condition	Intervention	Phase
Hypogonadism	Drug: Testosterone MD-Lotion	Phase III

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title:	A Phase III Open-Label Titration Trial to Evaluate the Effectiveness and Safety of Different Doses of a Dermal Application of Testosterone MD-Lotion® (Cutaneous Solution) in Hypogonadal Men

Further study details as provided by Acrux DDS Pty Ltd:

Primary Outcome Measures:

Pharmacokinetic [ Time Frame: 120 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	June 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Lotion/cutaneous solution

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Hypogonadal males aged at least 18 years of age 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: NCT00702650

Contacts

Contact: Tina Soulis, PhD

613-8379-0100 ext 0150

tina.soulis@acrux.com.au

Show 27 Study Locations

Sponsors and Collaborators

Acrux DDS Pty Ltd

Investigators

Study Director:

Tina Soulis, PhD

Acrux DDS Pty Ltd

More Information

Responsible Party:	Acrux Pharma Pty Ltd ( Tina Soulis, Director, Clinical Development )
Study ID Numbers:	MTE08
Study First Received:	June 19, 2008
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00702650
Health Authority:	United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medical Devices; Sweden: Medical Products Agency; France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Testosterone
Hypogonadism
Gonadal Disorders
Endocrine System Diseases

Methyltestosterone
Endocrinopathy
Testosterone 17 beta-cypionate

Additional relevant MeSH terms:

Anabolic Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions
Androgens

ClinicalTrials.gov processed this record on January 15, 2009