Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00522431
Status:
COMPLETED
Last Update Posted:
2017-10-05
First Post:
2007-08-28
Brief Title:
A Study of Fortigel Testosterone Gel 2 in Males With Low Testosterone
Sponsor:
Endo Pharmaceuticals
Organization:
Endo Pharmaceuticals
Study Overview
Official Title:
An Open Label Phase 3 Study of Fortigel Testosterone Gel 2 in Hypogonadal Males
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone The medical name for low testosterone is hypogonadism Hypogonadism can be caused by many factors Symptoms include decrease in libido lack of energy and mood swings The goal of testosterone replacement therapy is to return testosterone levels to the normal range and relieve symptoms
The purpose of this study is to evaluate the ability of Fortigel testosterone gel 2 to maintain serum blood testosterone levels within the normal range in hypogonadal men aged 18 to 75 years This will be determined by blood sampling at specified times during the study The study is also intended to evaluate the tolerability of Fortigel which will be applied to the skin each day throughout the study period
The purpose of this study is to evaluate the ability of Fortigel testosterone gel 2 to maintain serum blood testosterone levels within the normal range in hypogonadal men aged 18 to 75 years This will be determined by blood sampling at specified times during the study The study is also intended to evaluate the tolerability of Fortigel which will be applied to the skin each day throughout the study period
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None