Medroxyprogesterone Compared With Venlafaxine in Treating Hot Flashes in Women

Phase 3 Completed 227 enrolled Alliance for Clinical Trials in Oncology National Cancer Institute (NCI) · collab

RandomizedCrossoverOpen-labelSupportive care

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.

Timeline

Start: 2002-04
Primary completion: 2006-02
Completion: 2006-09

Outcome

Met primary endpoint

paper hot flash scores were reduced by 55% in the venlafaxine arm versus 79% in the MPA arm (P < .0001). PMID 16505409 ↗

paper A single MPA dose seems to be well tolerated and more effectively reduces hot flashes than does venlafaxine. PMID 16505409 ↗

Publications

Results Loprinzi CL, Levitt R, Barton D, Sloan JA, Dakhil SR, Nikcevich DA, Bearden JD 3rd, Mailliard JA, Tschetter LK, Fitch TR, Kugler JW. Phase III comparison of depomedroxyprogesterone acetate to venlafaxine for managing hot flashes: North Central Cancer Treatment Group Trial N99C7. J Clin Oncol. 2006 Mar 20;24(9):1409-14. doi: 10.1200/JCO.2005.04.7324. Epub 2006 Feb 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Venlafaxine	Small molecule	75 mg	Oral
Subject	medroxyprogesterone acetate	Other / unclassified	400 mg	Intramuscular

Indications

No indication recorded.