Testosterone Treatment for Hypogonadal Men
Information source: Solvay Pharmaceuticals
Information obtained from ClinicalTrials.gov on August 06, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypogonadism
Intervention: Testosterone Gel 1.62% (Drug)
Phase: Phase 3
Status: No longer recruiting
Sponsored by: Solvay Pharmaceuticals Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals
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: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Percentage of subjects with TT within the normal range
Secondary outcome: Evaluate safety for up to one year of use, TNF-alpha, IL-6, IL-10, hs-CRP, MMP-9, HDL2, HDL3, VCAM, D-Dimer, Fibrinogen, Bone-specific alkaline phosphatase, Type 1 cross-linked C telopeptide, SF-36 and % free PSA
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 PSA
Locations and Contacts
Additional Information
Starting date:
February 2007
Last updated: May 29, 2007
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