Testosterone Treatment for Hypogonadal Men
Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypogonadism
Intervention: Testosterone (T) Gel 1.62% (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Abbott Official(s) and/or principal investigator(s): Global Clinical Director Solvay, Study Director, Affiliation: Abbott Products
Summary
Demonstrate efficacy and safety of Testosterone Gel 1. 62% for the treatment of hypogonadal
men
Clinical Details
Official title: A Multi-Center, Randomized, Double-Blind,Placebo-Controlled Efficacy and Safety Study of Testosterone Gel 1.62% for the Treatment of Hypogonadal Men
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 112
Secondary outcome: Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 14Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 56 Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 182 Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266. Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 364.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Low T males 18 - 80 years of age
Exclusion Criteria:
- Normal T levels
- Elevated Prostatic Specific Antigen (PSA)
Locations and Contacts
Additional Information
Starting date: February 2007
Last updated: January 15, 2015
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