Treatment of Hot Flushes Caused by Leuprorelin 11.25 mg in Prostate Adenocarcinoma

Phase 3 Completed 311 enrolled Takeda

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to compare the efficacy of three drugs (cyproterone acetate, medroxyprogesterone acetate and venlafaxine) in the treatment of hot flushes caused by leuprorelin LP 11.25 milligram (mg) in participants suffering from prostate cancer.

Timeline

Start: 2004-04
Primary completion: 2007-12
Completion: 2007-12

Publications

Irani J, Salomon L, Oba R, Bouchard P, Mottet N. Efficacy of venlafaxine, medroxyprogesterone acetate, and cyproterone acetate for the treatment of vasomotor hot flushes in men taking gonadotropin-releasing hormone analogues for prostate cancer: a double-blind, randomised trial. Lancet Oncol. 2010 Feb;11(2):147-54. doi: 10.1016/S1470-2045(09)70338-9. Epub 2009 Dec 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Venlafaxine	Small molecule	75 mg	Oral
Subject	cyproterone acetate	Small molecule	50 mg	Oral
Subject	medroxyprogesterone acetate	Other / unclassified	10 mg	Oral
Background	Leuprolide	Other / unclassified	11.25 mg	Subcutaneous
Background	flutamide	Small molecule	250 mg	Oral

Treatment of Hot Flushes Caused by Leuprorelin 11.25 mg in Prostate Adenocarcinoma

Summary

Timeline

Publications

Drugs

Indications