Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05722301
Status:
WITHDRAWN
Last Update Posted:
2023-02-10
First Post:
2019-08-16
Brief Title:
Does Testosterone Therapy Improve Patient-Reported Outcomes in Age-Related Testosterone Deficient Patients Undergoing Total Hip Replacement A Randomized-Controlled Trial
Sponsor:
American Hip Institute
Organization:
American Hip Institute
Study Overview
Official Title:
Does Testosterone Therapy Improve Patient-Reported Outcomes in Age-Related Testosterone Deficient Patients Undergoing Total Hip Replacement A Randomized-Controlled Trial
Status:
WITHDRAWN
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was never initiated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized-controlled trial will study on the effect of testosterone therapy on patients undergoing total hip replacement Subjects will be male patients 50 years with testosterone deficiency undergoing total hip replacement due to severe degenerative joint disease All participants will receive a total hip replacement and will be randomized to either testosterone therapy or placebo A total of 80 subjects will be recruited randomized into 2 groups of 40 subjects Testosterone therapy will be administered once to each patient at 2 weeks before surgery The long-term follow up will be the same as all patients with patient-reported outcomes after total hip replacement VAS for pain and satisfaction at regular intervals
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None