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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00030914 |
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.
Condition | Intervention | Phase |
---|---|---|
Cancer-Related Problem/Condition |
Drug: medroxyprogesterone Drug: venlafaxine |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Active Control |
Official Title: | Phase III Comparison of Depomedroxyprogesterone Acetate (DPROV) to Venlafaxine for Managing Hot Flashes |
Study Start Date: | April 2002 |
OBJECTIVES:
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 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.)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Charles L. Loprinzi, MD | Mayo Clinic |
Study ID Numbers: | CDR0000069217, NCCTG-N99C7, NCI-P02-0204 |
Study First Received: | February 14, 2002 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00030914 |
Health Authority: | United States: Federal Government |
hot flashes |
Signs and Symptoms Medroxyprogesterone 17-Acetate Venlafaxine |
Hot Flashes Medroxyprogesterone Serotonin |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Contraceptive Agents Antineoplastic Agents Contraceptives, Oral Physiological Effects of Drugs Psychotropic Drugs Contraceptive Agents, Female |
Reproductive Control Agents Contraceptive Agents, Male Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Therapeutic Uses Contraceptives, Oral, Synthetic Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |