Hot Flashes Clinical Trial
Official title:
Phase III Comparison of Depomedroxyprogesterone Acetate (DPROV) to Venlafaxine for Managing Hot Flashes
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.
OBJECTIVES:
- Compare the efficacy of medroxyprogesterone administered as 1 injection vs
medroxyprogesterone administered as 3 injections (closed to accrual as of 1/22/03) 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 1/22/03.)
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.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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