Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT00594620
Status:
TERMINATED
Last Update Posted:
2022-02-14
First Post:
2008-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy
Sponsor:
University of Kansas Medical Center
Organization:
Study Overview
Official Title:
A Prospective Trial of Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy
Status:
TERMINATED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to poor accrual and without sufficient patients or data to report on any outcomes.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the efficacy of soy/isoflavone supplementation on hot flashes in men who are being treated with luteinizing hormone-releasing hormone (LHRH) agonist therapy for control of advanced prostate cancer
Detailed Description:
Literature has shown that low dose estrogens can control hot flashes in men on androgen deprivation but with a high risk of thromboembolic events. Soy derivatives that contain isoflavones, a type of phytoestrogen, have been evaluated in peri-menopausal women as a possible safer alternative to synthetic estrogens but there has not been a similar study performed on their effect in men on androgen deprivation therapy for prostate cancer.
Study Oversight
Has Oversight DMC:
False
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?: