Clinical Trial: Medroxyprogesterone Compared With Venlafaxine in Treating Hot Flashes in Women

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Alliance for Clinical Trials in Oncology

Current Primary Outcome: Compare the efficacy of the three regimens [ Time Frame: Up to one year post-treatment ]

Original Primary Outcome:

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

Information By: Alliance for Clinical Trials in Oncology

Dates:
Date Received: February 14, 2002
Date Started: April 2002
Date Completion:
Last Updated: July 12, 2016
Last Verified: July 2016