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

NCT01011751 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 311

Last updated 2015-07-30

No results posted yet for this study

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.

Conditions

  • Adenocarcinoma, Prostate

Interventions

DRUG

Cyproterone acetate

Cyproterone acetate tablet-in-capsule.

DRUG

Medroxyprogesterone acetate

Medroxyprogesterone acetate tablet-in-capsule.

DRUG

Venlafaxine

Venlafaxine capsule.

DRUG

Leuprorelin

Leuprorelin injection.

DRUG

Flutamide

Flutamide tablet

DRUG

Placebo

Cyproterone acetate, medroxyprogesterone acetate or venlafaxine placebo-matching capsule.

Sponsors & Collaborators

Principal Investigators

  • jacques irani, MD · Poitiers hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • France

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01011751 on ClinicalTrials.gov