Phase III Comparison of Depomedroxyprogesterone Acetate (DPROV) to Venlafaxine for Managing 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.
- 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.)
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
Charles L. Loprinzi, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000069217
NCT00030914
April 2002
Name | Location |
---|---|
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
MBCCOP - Hawaii | Honolulu, Hawaii 96813 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
CCOP - Duluth | Duluth, Minnesota 55805 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay, Wisconsin 54301 |
CCOP - Oklahoma | Tulsa, Oklahoma 74136 |
Allegheny General Hospital | Pittsburgh, Pennsylvania 15212-4772 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
Medcenter One Health System | Bismarck, North Dakota 58501 |
Coborn Cancer Center | Saint Cloud, Minnesota 56303 |
CCOP - Mayo Clinic Scottsdale Oncology Program | Scottsdale, Arizona 85259 |