Phase III Comparison of Depomedroxyprogesterone Acetate (DPROV) to Venlafaxine for Managing Hot Flashes
- 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.
- Arm I: Patients receive oral venlafaxine once daily for 6 weeks beginning on day 8.
After week 7, patients with satisfactory efficacy may continue venlafaxine for up to 6
months. Patients with unsatisfactory efficacy may cross over to arm III.
- Arm II (closed to accrual as of 1/22/03): Patients receive medroxyprogesterone
intramuscularly (IM) on days 8, 22, and 36 for a total of 3 injections. After week 7,
patients with unsatisfactory efficacy may cross over to arm I.
- Arm III: Patients receive medroxyprogesterone IM once on day 8. After week 7, patients
with unsatisfactory efficacy may cross over to arm I.
Patients are followed at months 2, 3, 4, 5, 6, 8, 10, and 12.
PROJECTED ACCRUAL: A total of 220 patients (110 per treatment arm) will be accrued for this
study within 18 months. (Arm II closed to accrual as of 1/22/03.)
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
Charles L. Loprinzi, MD
United States: Federal Government
|Mayo Clinic - Jacksonville||Jacksonville, Florida 32224|
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