Status:
COMPLETED
ESPRIT Study in Hypogonadal Men
Lead Sponsor:
Abbott
Collaborating Sponsors:
Fovea
Conditions:
Hypogonadism
Eligibility:
MALE
18+ years
Brief Summary
Observational study with AndroGel®, Testosterone 1% gel therapy (ESPRIT) in hypogonadal men in the community over 6 months.
Detailed Description
The objective of this study was to evaluate the efficacy and safety of AndroGel (testosterone gel) 1% following administration in community dwelling men with hypogonadism. The percent change from base...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Male patients \>= 18 years of age
- Hypogonadism not previously treated with testosterone
- Testosterone deficiency confirmed clinically and biochemically
- Being prescribed AndroGel® 1% in accordance with the local summary of product characteristics
- Exclusion Criteria
- According to the contra-indications,
- Unwilling or unable to sign informed consent form
Exclusion
Key Trial Info
Start Date :
December 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
1053 Patients enrolled
Trial Details
Trial ID
NCT01143818
Start Date
December 1 2007
End Date
August 1 2010
Last Update
October 17 2011
Active Locations (331)
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1
Site Ref # / Investigator 59749
Burnaby, British Columbia, Canada, V5G 1T4
2
Site Ref # / Investigator 59765
Coquitlam, British Columbia, Canada, V3B 6S2
3
Site Ref # / Investigator 59742
Kamloops, British Columbia, Canada, V2C 5Y2
4
Site Ref # / Investigator 59775
Kelowna, British Columbia, Canada, V1X 7N6