NCT00030914

Medroxyprogesterone Compared With Venlafaxine in Treating Hot Flashes in Women

Phase III Comparison of Depomedroxyprogesterone Acetate (DPROV) to Venlafaxine for Managing Hot Flashes

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 227 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hot Flashes

Interventions

Type	Name	Description
DRUG	medroxyprogesterone
DRUG	venlafaxine

Timeline

• Start date: 2002-04-01
• Primary completion: 2006-02-01
• Completion: 2006-09-01
• First posted: 2003-01-27
• Last updated: 2016-07-13

Locations

22 sites across 1 country: United States