Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398580
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2006-11-08
Brief Title:
28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase II 28-Day Randomized Parallel-Group Open-Label Study Evaluating the Efficacy and Safety of Twice Daily Oral Doses of Testosterone 150-400mg Co-administered With 025mg Dutasteride Compared With 400mg Testosterone Alone and 025mg Dutasteride Alone in the Treatment of Hypogonadism
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The combination of testosterone and dutasteride is intended for use in hypogonadal men This study will evaluate the effect of 28-day repeat dosing of this combination with varying BID doses of testosterone T in combination with a fixed BID dose of dutasteride D as well as a testosterone alone arm on T and D levels in the blood The rationale is to look for the effects of each compound on the other and to look for any safety problems that may result when the 2 drugs are given together
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