A Phase 3 interventional study of medroxyprogesterone and venlafaxine in Hot Flashes, sponsored by Alliance for Clinical Trials in Oncology. Completed at 22 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-13.
Sponsored by Alliance for Clinical Trials in Oncology · Phase 3, Interventional, and Supportive care
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:
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.
285 studies on the registry are indexed under Hot Flashes; 50 are open to participants now.
This study's enrollment of 227 is above the median of 90 across 255 interventional studies indexed under Hot Flashes.
Browse Hot Flashes studies →Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Sex:
Performance status:
Life expectancy:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Chemotherapy:
Endocrine therapy:
Other:
All patients complete a daily questionnaire regarding number of hot flashes beginning on day 1 and continuing for 7 weeks. 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. Patients are followed at months 2, 3, 4, 5, 6, 8, 10, and 12.
Drug: venlafaxine
All patients complete a daily questionnaire regarding number of hot flashes beginning on day 1 and continuing for 7 weeks. 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. Patients are followed at months 2, 3, 4, 5, 6, 8, 10, and 12.
Drug: medroxyprogesterone
All patients complete a daily questionnaire regarding number of hot flashes beginning on day 1 and continuing for 7 weeks. 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.
Drug: medroxyprogesterone
Compare the efficacy of the three regimens
Time frame: Up to one year post-treatment
Determine whether there is cross resistance between these 2 drugs in these patients
Time frame: Up to 1 year post-treatment
Compare the 1-year efficacy of these regimens in these patients
Time frame: Up to 1 year post-treatment
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Alliance for Clinical Trials in Oncology