Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030914
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2002-02-14
Brief Title:
Medroxyprogesterone Compared With Venlafaxine in Treating Hot Flashes in Women
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase III Comparison of Depomedroxyprogesterone Acetate DPROV to Venlafaxine for Managing Hot Flashes
Status:
COMPLETED
Status Verified Date:
2016-07
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:
RATIONALE Medroxyprogesterone and venlafaxine may be effective in relieving hot flashes It is not yet known whether venlafaxine is more effective than medroxyprogesterone in relieving hot flashes
PURPOSE Randomized phase III trial to compare the effectiveness of medroxyprogesterone with that of venlafaxine in treating women who are experiencing hot flashes
PURPOSE Randomized phase III trial to compare the effectiveness of medroxyprogesterone with that of venlafaxine in treating women who are experiencing hot flashes
Detailed Description:
OBJECTIVES
Compare the efficacy of medroxyprogesterone administered as 1 injection vs medroxyprogesterone administered as 3 injections closed to accrual as of 12203 vs venlafaxine for hot flash alleviation in women with symptomatic hot flashes
Compare the toxic effects of these regimens in these patients
Determine whether there is cross resistance between these 2 drugs in these patients
Compare the 1-year efficacy of these regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to age 18 to 49 vs 50 and over current tamoxifen use yes vs no current raloxifene use yes vs no duration of hot flash symptoms less than 9 months vs 9 months or more and average frequency of hot flashes per day 2-3 vs 4-9 vs 10 or more Patients are randomized to 1 of 2 treatment arms Arm II closed to accrual as of 12203
All patients complete a daily questionnaire regarding number of hot flashes beginning on day 1 and continuing for 7 weeks Patients are randomized to one of three treatment arms
Compare the efficacy of medroxyprogesterone administered as 1 injection vs medroxyprogesterone administered as 3 injections closed to accrual as of 12203 vs venlafaxine for hot flash alleviation in women with symptomatic hot flashes
Compare the toxic effects of these regimens in these patients
Determine whether there is cross resistance between these 2 drugs in these patients
Compare the 1-year efficacy of these regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to age 18 to 49 vs 50 and over current tamoxifen use yes vs no current raloxifene use yes vs no duration of hot flash symptoms less than 9 months vs 9 months or more and average frequency of hot flashes per day 2-3 vs 4-9 vs 10 or more Patients are randomized to 1 of 2 treatment arms Arm II closed to accrual as of 12203
All patients complete a daily questionnaire regarding number of hot flashes beginning on day 1 and continuing for 7 weeks Patients are randomized to one of three treatment arms
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000069217 | REGISTRY | None | None |
| NCI-P02-0204 | Registry Identifier | PDQ Physician Data Query | None |