Pharmacokinetics of Testosterone Lotion in the Treatment of Hypogonadal Males

This study has been completed.
Sponsor:
Information provided by:
Acrux DDS Pty Ltd
ClinicalTrials.gov Identifier:
NCT00372008
First received: September 5, 2006
Last updated: June 18, 2008
Last verified: June 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Alabama
Birmingham
Birmingham, Alabama, United States
United States, California
La Mesa, California, United States
Torrance, 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

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

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on August 21, 2014