Pharmacokinetics of Testosterone Lotion in the Treatment of Hypogonadal Males
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
1 other identifier
interventional
40
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2006
Shorter than P25 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2006
CompletedFirst Posted
Study publicly available on registry
September 6, 2006
CompletedStudy Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedJune 20, 2008
June 1, 2008
6 months
September 5, 2006
June 18, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic
Secondary Outcomes (1)
Safety and tolerability
Interventions
Eligibility Criteria
You may qualify if:
- Hypogonadal males between 18-70 years old with qualifying general medical health
You may not qualify if:
- Disqualifying concurrent conditions or allergy/sensitivity to testosterone replacement therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Birmingham
Birmingham, Alabama, United States
Unknown Facility
La Mesa, California, United States
Unknown Facility
Torrance, California, United States
Unknown Facility
New Britain, Connecticut, United States
Unknown Facility
Ocala, Florida, United States
Unknown Facility
Shreveport, Louisiana, United States
Unknown Facility
San Antonio, Texas, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tina Soulis, PhD
Acrux Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 5, 2006
First Posted
September 6, 2006
Study Start
October 1, 2006
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
June 20, 2008
Record last verified: 2008-06