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

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

Outcome

Met primary endpoint

paper The decrease from baseline was significant for all three groups (p<0.0001). PMID 19963436 ↗

paper cyproterone and medroxyprogesterone groups than in the venlafaxine group, regardless of the interval considered (p<0.0001 in all cases). PMID 19963436 ↗

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	Flutamide	Small molecule	250 mg	Oral
Background	Leuprolide	Other / unclassified	11.25 mg	Subcutaneous

Indications