Efficacy and Tolerance of Cyproterone Acetate Versus Medroxyprogesterone Acetate Versus Venlafaxine LP in the Treatment of Hot Flushes Caused by Leuprorelin 11.25 mg in Patients Treated for a Prostate Adenocarcinoma
Primary objective:
To compare the efficacy of 3 drugs (cyproterone acetate, medroxyprogesterone acetate,
venlafaxine) in the treatment of hot flushes caused by leuprorelin LP 11.25 mg in patients
suffering from prostate cancer: frequency and severity of hot flushes.
Secondary objectives:
To evaluate in each treatment group:
- the tolerance profile of the study drugs,
- the impact of the treatment on the quality of life of patients and their satisfaction,
- the change in the frequency and severity of hot flushes after 4 and 8 weeks of
treatment,
- the proportion of patients who wish to continue treatment after the end of the study.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
HOT FLUSHES score in week 4 of treatment after randomisation (variation in average score compared with evaluation at randomisation visit V1, expressed as a percentage).
in week 4 of treatment after randomisation
No
jacques irani, MD
Principal Investigator
Poitiers hospital
France: Institutional Ethical Committee
F-LEU-100
NCT01011751
April 2004
December 2007
Name | Location |
---|